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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II January 22, 2014 guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/… Aidapak Services, LLC Terminated
Class II January 22, 2014 tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as PYRIDOXINE HCL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guaiFENesin ER, Tablet, 600… Aidapak Services, LLC Terminated
Class II January 22, 2014 COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as rifAXIMin, Tablet, 200 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by:… Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN,… Aidapak Services, LLC Terminated
Class II January 22, 2014 CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service,… Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE,… Aidapak Services, LLC Terminated
Class II January 22, 2014 RAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901 Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150… Aidapak Services, LLC Terminated
Class II January 22, 2014 LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110 Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 DOXYCYCLINE HYCLATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; DOXYCYCLINE HYCLATE, Tablet, 100 mg may be potentially mislabeled as DESLORATADINE, Tablet, 5… Aidapak Services, LLC Terminated
Class II January 22, 2014 CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak… Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as… Aidapak Services, LLC Terminated
Class II January 22, 2014 ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC… Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 180 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600… Aidapak Services, LLC Terminated
Class II January 22, 2014 VITAMIN B COMPLEX PROLONGED RELEASE Tablet, 50 mg, Over The Counter, Distributed by:… Labeling: Label Mixup; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg may be potentially mislabeled as COENZYME… Aidapak Services, LLC Terminated
Class II January 22, 2014 PANTOPRAZOLE SODIUM DR Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule,… Aidapak Services, LLC Terminated
Class II January 22, 2014 MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141509 Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 NAPROXEN, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 05374601901 Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS,… Aidapak Services, LLC Terminated
Class II January 22, 2014 OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service,… Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as tiZANidine HCL, Tablet, 2… Aidapak Services, LLC Terminated
Class II January 22, 2014 QUINAPRIL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; QUINAPRIL HCL Tablet, 10 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 80 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy,… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 HYDRALAZINE HCL Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; HYDRALAZINE HCL Tablet, 25 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240… Aidapak Services, LLC Terminated
Class II January 22, 2014 FLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PHOSPHORUS Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980010401 Labeling: Label Mixup; PHOSPHORUS Tablet, 250 mg may be potentially mislabeled as CITALOPRAM, Tablet, 10 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY,… Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar… Sigma-Tau Pharmaceuticals, Inc. Terminated
Class II January 22, 2014 NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250… Aidapak Services, LLC Terminated
Class II January 22, 2014 MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as QUETIAPINE FUMARATE, Tablet, 12.5 MG… Aidapak Services, LLC Terminated
Class II January 22, 2014 clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 BENAZEPRIL HCL Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron), Over The Counter, Distributed by:… Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as… Aidapak Services, LLC Terminated
Class II January 22, 2014 NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 MELATONIN Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 BENAZEPRIL HCL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722053001 Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 GLIMEPIRIDE Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111032001 Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 LACTOBACILLUS ACIDOPHILUS Capsule, Over The Counter, Distributed by: AidaPak Service,… Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000… Aidapak Services, LLC Terminated
Class II January 22, 2014 HYDROXYCHLOROQUINE SULFATE Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl,… Aidapak Services, LLC Terminated
Class II January 22, 2014 MULTIVITAMIN/MULTIMINERAL Tablet, Over The Counter, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as QUEtiapine FUMARATE, Tablet,… Aidapak Services, LLC Terminated
Class II January 22, 2014 hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; traMADol HCl Tablet, 25 mg (1/2 of 50 mg) may be potentially mislabeled as LEVOTHYROXINE SODIUM,… Aidapak Services, LLC Terminated
Class II January 22, 2014 LACTOBACILLUS ACIDOPHILUS Capsule, 500 Million CFU, Over The Counter, Distributed by:… Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE… Aidapak Services, LLC Terminated
Class II January 22, 2014 LACTOBACILLUS GG Capsule, 10 Billion Cells, Over The Counter, Distributed by: AidaPak… Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER,… Aidapak Services, LLC Terminated
Class II January 22, 2014 OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service,… Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mislabeled as NORTRIPTYLINE HCL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 carBAMazepine ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; carBAMazepine ER Tablet, 200 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 COENZYME Q-10, Capsule 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; COENZYME Q-10 Capsule, 100 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300… Aidapak Services, LLC Terminated
Class II January 22, 2014 FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20… Aidapak Services, LLC Terminated
Class II January 22, 2014 MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: AidaPak… Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM,… Aidapak Services, LLC Terminated
Class II January 22, 2014 Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak… Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet,… Aidapak Services, LLC Terminated
Class II January 22, 2014 QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak… Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PRAMIPEXOLE DI-HCL Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 MELATONIN Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as hydrOXYzine PAMOATE, Capsule, 100 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 medroxyPROGESTERone ACETATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl,… Aidapak Services, LLC Terminated
Class II January 22, 2014 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 ACARBOSE, Tablet 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155014701 Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class III January 22, 2014 Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine… Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Novartis Consumer Health Terminated
Class II January 22, 2014 MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service,… Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5… Aidapak Services, LLC Terminated
Class II January 22, 2014 HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH… Aidapak Services, LLC Terminated
Class II January 22, 2014 QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule, 100 mg, Rx only, Distributed by:… Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as… Aidapak Services, LLC Terminated
Class II January 22, 2014 METOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as Pedigree: AD73652_13,… Aidapak Services, LLC Terminated
Class II January 22, 2014 ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500… Aidapak Services, LLC Terminated
Class II January 22, 2014 aMILoride HCl Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64980015101 Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 PSEUDOEPHEDRINE HCL, Tablet, 30 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400… Aidapak Services, LLC Terminated
Class II January 22, 2014 ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only,… Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially… Aidapak Services, LLC Terminated
Class II January 22, 2014 MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503 Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5… Aidapak Services, LLC Terminated
Class II January 22, 2014 QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; ATORVASTATIN CALCIUM, Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule,… Aidapak Services, LLC Terminated
Class II January 22, 2014 POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 DOXEPIN HCL Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; DOXEPIN HCL Capsule, 150 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule,… Aidapak Services, LLC Terminated
Class II January 22, 2014 SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; SEVELAMER HCl Tablet, 800 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 VITAMIN B COMPLEX, Tablet Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; VITAMIN B COMPLEX Tablet may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak… Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as CYANOCOBALAMIN,… Aidapak Services, LLC Terminated
Class II January 22, 2014 DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE… Aidapak Services, LLC Terminated
Class II January 22, 2014 OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak… Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as… Aidapak Services, LLC Terminated
Class II January 22, 2014 LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303 Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101 Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE,… Aidapak Services, LLC Terminated
Class II January 22, 2014 QUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001 Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak… Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE… Aidapak Services, LLC Terminated
Class II January 22, 2014 VERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1… Aidapak Services, LLC Terminated
Class III January 22, 2014 Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine… Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Novartis Consumer Health Terminated
Class II January 22, 2014 PSEUDOEPHEDRINE HCL, Tablet, 60 mg, Rx in Oregon, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PIMOZIDE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701 Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000… Aidapak Services, LLC Terminated
Class II January 22, 2014 ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194… Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg… Aidapak Services, LLC Terminated
Class II January 22, 2014 D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units, Over The Counter, Distributed by: AidaPak… Labeling: Label Mixup; D-ALPHA TOCOPHERYL ACETATE Capsule, 400 units may be potentially mislabeled as CYANOCOBALAMIN,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by:… Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10,… Aidapak Services, LLC Terminated
Class II January 22, 2014 SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding… Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled… Specialty Medicine Compounding Pharmacy Terminated
Class II January 22, 2014 traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2… Aidapak Services, LLC Terminated
Class II January 22, 2014 carBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PIMOZIDE Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet,… Aidapak Services, LLC Terminated
Class II January 22, 2014 IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830 Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 BISACODYL EC, Tablet, 5 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; BISACODYL EC, Tablet, 5 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units,… Aidapak Services, LLC Terminated
Class II January 22, 2014 NEOMYCIN SULFATE Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling: Label Mixup; NEOMYCIN SULFATE, Tablet, 500 mg may be potentially mislabeled as IMIPRAMINE HCL, Tablet, 25 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC,… Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50… Aidapak Services, LLC Terminated
Class II January 22, 2014 MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service,… Labeling: Label Mixup; MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as LISINOPRIL, Tablet, 2.5 mg,… Aidapak Services, LLC Terminated
Class II January 22, 2014 FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830 Labeling: Label Mixup; FEBUXOSTAT Tablet, 40 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing,… CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing… Betachem, Inc. Terminated
Class II January 22, 2014 NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg, Rx only, Distributed by: AidaPak Service,… Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE,… Aidapak Services, LLC Terminated
Class II January 22, 2014 OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 FLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130 Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 OLANZAPINE, Tablet 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505311203 Labeling:Label Mixup; OLANZAPINE, Tablet 7.5 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303 Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID,… Aidapak Services, LLC Terminated
Class II January 22, 2014 PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak… Labeling: Label Mixup; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet may be potentially mislabeled as RILUZOLE, Tablet, 50… Aidapak Services, LLC Terminated
Class II January 22, 2014 CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed… Labeling: Label Mixup; CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium) may be potentially mislabeled as… Aidapak Services, LLC Terminated
Class II January 22, 2014 TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50742020801 Labeling: Label Mixup; TACROLIMUS, Capsule, 1 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 125… Aidapak Services, LLC Terminated
Class II January 22, 2014 GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak… Labeling:Label Mixup; GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg may be potentially mislabeled as FEXOFENADINE HCL,… Aidapak Services, LLC Terminated
Class II January 22, 2014 NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401 Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/… Aidapak Services, LLC Terminated
Class II January 22, 2014 rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103 Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC… Aidapak Services, LLC Terminated
Class II January 22, 2014 PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC… Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet,… Aidapak Services, LLC Terminated
Class I January 22, 2014 Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira,… Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible… Hospira Inc. Terminated
Class II January 22, 2014 Quinapril Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lupin… Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the… Lupin Pharmaceuticals Inc. Terminated
Class II January 22, 2014 Quinapril Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lupin… Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the… Lupin Pharmaceuticals Inc. Terminated
Class II January 22, 2014 SODIUM CHLORIDE 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical… Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter). B. Braun Medical Inc Terminated
Class III January 22, 2014 Zithromax Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion… Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for… Pfizer Inc. Terminated
Class III January 15, 2014 Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07),… Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical… Mutual Pharmaceutical Company, Inc. Terminated
Class II January 15, 2014 Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Compounding Centre At Blue Ridge Terminated
Class III January 15, 2014 FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90… Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical… Mutual Pharmaceutical Company, Inc. Terminated
Class II January 15, 2014 PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Compounding Centre At Blue Ridge Terminated
Class III January 15, 2014 Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual… Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical… Mutual Pharmaceutical Company, Inc. Terminated
Class II January 15, 2014 Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Compounding Centre At Blue Ridge Terminated
Class II January 15, 2014 Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Compounding Centre At Blue Ridge Terminated
Class II January 15, 2014 Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's… Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to… Compounding Centre At Blue Ridge Terminated
Class II January 15, 2014 Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson… Presence of Foreign Substance; metal particulates were visually observed in the tablets. Watson Laboratories Inc Terminated
Class II January 8, 2014 Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva… Failed Tablet/Capsule Specifications: There is a potential for broken tablets. Teva Pharmaceuticals USA Terminated
Class III January 8, 2014 Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120… Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. Qualitest Pharmaceuticals Terminated
Class II January 8, 2014 Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets,… Subpotent; Hydrochlorothiazide at the 9 month time point. Sandoz Inc Terminated
Class II January 8, 2014 Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx… Presence of Precipitate; precipitation of drug product Teva Pharmaceuticals USA Terminated
Class III January 8, 2014 fluocinolone acetonide G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC… Failed Content Uniformity Specifications; at the 18 month time point. G & W Laboratories Inc Terminated
Class II January 8, 2014 Bupivacaine Hydrochloride 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial,… Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Hospira Inc. Terminated
Class II January 1, 2014 Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA… Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical… Airgas Medical Services Terminated
Class II January 1, 2014 Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90… Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability… Amedra Pharmaceuticals LLC Terminated
Class II January 1, 2014 Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2… Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the… GlaxoSmithKline, LLC. Terminated
Class III January 1, 2014 Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech… Failed Stability Specification; product viscosity and or pH are below specification. Hi-Tech Pharmacal Co., Inc. Terminated
Class III January 1, 2014 Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays,… Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered… Teva Pharmaceuticals USA Terminated
Class II January 1, 2014 Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals… Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were… Physicians Total Care, Inc. Terminated
Class II January 1, 2014 Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown… Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because… Tower Pharmacy and Compounding Terminated
Class II January 1, 2014 Tacrolimus Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by… Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product… Sandoz Incorporated Terminated
Class II January 1, 2014 IMITREX Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL… Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the… GlaxoSmithKline, LLC. Terminated
Class I December 25, 2013 Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold… Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative… Altaire Pharmaceuticals, Inc. Terminated
Class II December 25, 2013 Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel… Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal… Airgas Medical Services Terminated
Class I December 25, 2013 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule… Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil Fabscout Entertainment, Inc Terminated
Class III December 25, 2013 LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz,… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class I December 25, 2013 Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By… Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain… Healthy Life Chemistry Inc dba Purity First Terminated
Class II December 25, 2013 Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward… Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were… West-Ward Pharmaceutical Corp. Terminated
Class III December 25, 2013 I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class I December 25, 2013 B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity… Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and… Healthy Life Chemistry Inc dba Purity First Terminated
Class III December 25, 2013 I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class I December 25, 2013 Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang… Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil Fabscout Entertainment, Inc Terminated
Class I December 25, 2013 Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang… Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in… Zi Xiu Tang Success, LLC Terminated
Class I December 25, 2013 Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle,… Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in… Zi Xiu Tang Success, LLC Terminated
Class III December 25, 2013 Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt.… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class I December 25, 2013 Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa,… Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and… Bethel Nutritional Consulting, Inc Terminated
Class III December 25, 2013 Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany,… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class I December 25, 2013 Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed,… Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein,… Bethel Nutritional Consulting, Inc Terminated
Class III December 25, 2013 yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz,… Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl… Tween Brands Inc Terminated
Class III December 25, 2013 FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx… Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Fresenius Kabi USA, LLC Terminated
Class I December 25, 2013 PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per… Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil Fabscout Entertainment, Inc Terminated
Class I December 25, 2013 Bupivacaine Hydrochloride 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake… Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. Hospira Inc. Terminated
Class II December 25, 2013 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct… Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured Baxter Healthcare Corp. Terminated
Class I December 25, 2013 Bupivacaine Hydrochloride 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake… Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. Hospira Inc. Terminated
Class II December 18, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class I December 18, 2013 Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop… Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary… Myson Corporation, Inc. Terminated
Class II December 18, 2013 Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class III December 18, 2013 Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters… SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the… Boehringer Ingelheim Roxane Inc Terminated
Class II December 18, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class II December 18, 2013 Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class I December 18, 2013 Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com,… Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary… Myson Corporation, Inc. Terminated
Class II December 18, 2013 Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale,… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge,… Novartis Pharmaceuticals Corp. Terminated
Class III December 18, 2013 ciclopirox Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals… Subpotent. drug Taro Pharmaceuticals U.S.A., Inc. Terminated
Class II December 18, 2013 Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only,… Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and… VistaPharm, Inc. Terminated
Class III December 18, 2013 Bumetanide Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz… Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing… Sandoz Inc Terminated
Class III December 18, 2013 Ethambutol Hydrochloride Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured… Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for… Lupin Pharmaceuticals Inc. Terminated
Class II December 11, 2013 Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged… Subpotent American Health Packaging Terminated
Class II December 11, 2013 Medroxyprogesterone (PF) 150mg/10ml, Main Street Compounding Pharmacy, 126 East Main… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 370iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Methylprednisolone 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellets 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Test Cypionate 20mg/ml 5ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 270 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 AMIC-12 w/out lido10ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Pre-Menopausal Pack 3rd Month, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 340 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Mic 25/50/50 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellets 12mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Betamethasone NA Phosphate (PF) 6mg/ml 10ml, Main Street Compounding Pharmacy, 126 East… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellets 31mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Mic B-Complex 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellets 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Hydrogen Peroxide 3% 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 G-A-C Amino Cocktail 30ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 L-Arginine 100mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Alprostadil 20mcg/ml 25ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Betamethasone 6.5mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 1500iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Marcaine .2%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 B-12 mixture, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Lipotonix Plus-Mic B complex, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 500u/ml w/methylc. 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Betamethasone 7mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 HCG 330 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated
Class II December 11, 2013 Estradiol Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded… Main Street Family Pharmacy, LLC Terminated