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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 February 3, 2016 CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX,… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class III February 3, 2016 Tropicamide Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59)… Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc. Terminated
Class II February 3, 2016 Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b)… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA… Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises Terminated
Class II February 3, 2016 Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total… Subpotent drug. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only,… Stability data does not support expiry. Pharmakon Pharmaceuticals Terminated
Class II February 3, 2016 Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing… Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on… Perrigo Company PLC Terminated
Class II February 3, 2016 Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5… Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on… Perrigo Company PLC Terminated
Class II January 27, 2016 Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container),… Presence of Foreign Substance Freedom Pharmaceuticals Inc Terminated
Class II January 27, 2016 Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL… Lack of Assurance of Sterility: Failed preservative effectiveness test Mayne Pharma Usa Terminated
Class II January 27, 2016 Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for… Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Pine Pharmaceuticals, LLC Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx --… Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Pine Pharmaceuticals, LLC Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine… Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Pine Pharmaceuticals, LLC Terminated
Class II January 27, 2016 Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine… Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. Pine Pharmaceuticals, LLC Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR… Lack of Assurance of Sterility Amerita Specialty Infusion Services Terminated
Class III January 27, 2016 Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC… Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. Morton Grove Pharmaceuticals, Inc. Terminated
Class II January 27, 2016 Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles,… Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic… Grato Holdings, Inc. Terminated
Class II January 27, 2016 Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count… Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the… Mutual Pharmaceutical Company, Inc. Terminated
Class II January 27, 2016 Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by… Lack of Assurance of Sterility Amerita Specialty Infusion Services Terminated
Class III January 27, 2016 Phentermine Hydrochloride Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC… Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at… PD-Rx Pharmaceuticals, Inc. Terminated
Class II January 20, 2016 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only,… Presence of Particulate Matter Amerisource Health Services Terminated
Class III January 20, 2016 Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per… Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. National Vitamin Co Inc Terminated
Class II January 20, 2016 Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged… Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. Freedom Pharmaceuticals Inc Terminated
Class II January 20, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND… Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability… Teva Pharmaceuticals USA Terminated
Class II January 13, 2016 Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count… cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately… PD-Rx Pharmaceuticals, Inc. Terminated
Class III January 13, 2016 EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only,… Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP… PQ Corporation Terminated
Class III January 13, 2016 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5… Subpotent Drug Freedom Pharmaceuticals Inc Terminated
Class II January 13, 2016 Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and… cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately… PD-Rx Pharmaceuticals, Inc. Terminated
Class III January 13, 2016 Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance… Failed Impurities/Degradation Specifications: Out of specifications results for impurities. Avantor Performance Materials Inc Terminated
Class II January 6, 2016 Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by… cGMP Deviations PD-Rx Pharmaceuticals, Inc. Terminated
Class II January 6, 2016 Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c)… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class II January 6, 2016 Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio,… Lack of Assurance of Sterility Walgreens Infusion Services Terminated
Class III December 30, 2015 HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private… Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc. Terminated
Class III December 30, 2015 HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS… Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc. Terminated
Class III December 30, 2015 HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL… Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet specification at expiry. Oasis Medical, Inc. Terminated
Class III December 30, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the… Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Perrigo Company PLC Terminated
Class III December 23, 2015 Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx… Labeling: Incorrect or Missing Lot AND/OR Exp Date. Teva Pharmaceutical Industries Terminated
Class II December 16, 2015 Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class II December 16, 2015 Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class II December 16, 2015 Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class III December 16, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01)… Failed Impurities/Degradation Specifications: Out of specification for impurities. Golden State Medical Supply Inc. Terminated
Class II December 16, 2015 Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class II December 16, 2015 Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl… Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to… Steris Corp Terminated
Class II December 16, 2015 Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class III December 16, 2015 MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only.… Failed Impurities/Degradation Specifications: Out of specification for impurities. Golden State Medical Supply Inc. Terminated
Class II December 16, 2015 Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class II December 16, 2015 Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis,… Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage… RemedyRepack Inc. Terminated
Class III December 16, 2015 Norpace Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a)… Failed Dissolution Specification Pfizer Inc. Terminated
Class II December 16, 2015 VENTOLIN Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered… Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200… GlaxoSmithKline, LLC Terminated
Class II December 9, 2015 T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit… Discoloration Nephron Pharmaceuticals Corp. Terminated
Class II December 9, 2015 Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Vitamin B-Complex 100 Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E.… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Testost CYP 200mg/mL SUS, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 HCG 1000unit/10mL MTU vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Depo-Testadiol 10/5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b)… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Geritrex Corp Terminated
Class II December 9, 2015 Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy… Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life Science… Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Geritrex Corp Terminated
Class II December 9, 2015 Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only,… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Geritrex Corp Terminated
Class II December 9, 2015 Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only,… Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. Geritrex Corp Terminated
Class III December 9, 2015 Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX… Labeling: Not elsewhere classified. NDC number is incorrect on the container. Northwind Pharmaceuticals LLC Terminated
Class II December 9, 2015 Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street,… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY Penicillin Cross Contamination: potentially contaminated with penicillin Life Science Pharmacy Inc Terminated
Class II December 9, 2015 Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona… Lack of Assurance of Sterility Western Drug Terminated
Class II December 9, 2015 Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine… Discoloration Nephron Pharmaceuticals Corp. Terminated
Class II December 2, 2015 Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC… Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices… Qualgen Terminated
Class II December 2, 2015 Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC… Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices… Qualgen Terminated
Class I November 25, 2015 LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box… Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. Blue Square Market, Inc. Terminated
Class I November 25, 2015 KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box,… Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil. Blue Square Market, Inc. Terminated
Class II November 25, 2015 HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only,… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR… Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound… Solutions Rx Pharmacy Terminated
Class II November 25, 2015 Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg,… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient… US Compounding Inc Terminated
Class II November 25, 2015 HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only,… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only,… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd,… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001… Lack of Assurance of Sterility Downing Labs, LLC Terminated
Class II November 25, 2015 HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N.… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated
Class II November 25, 2015 TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness… Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to… Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Terminated