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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 August 14, 2019 Mental Tonic Capsules, Herbal Doctor Remedies, Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MAGNESIUM CHLORIDE HEXAHYDRATE (MDV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340… Crystallization RXQ Compounding LLC Terminated
Class II August 14, 2019 Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89; b) 55 ML… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 PHO-TID-CHOL 50MG/ DEOXYCHOLIC 42 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-0197-92; c)… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding,… Crystallization RXQ Compounding LLC Terminated
Class II August 14, 2019 Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Thyro-H, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Pain Away, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Bone Fixer, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Street, Unit 9,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Thyro-Lo, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Lube Lax Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… Unipharma, Llc. Terminated
Class II August 14, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial, RXQ… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Lipidtrol Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 CALCIUM GLUCONATE 5% INJECTION SOLUTION (MDV), 20 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.… Unipharma, Llc. Terminated
Class II August 14, 2019 Yeast Douche Powder, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Vertigo Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30ML NDC:… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Awake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class III August 14, 2019 Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC… Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied… AAA Pharmaceutical, Inc. Terminated
Class II August 14, 2019 TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Compounding,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding, 340 West… Crystallization RXQ Compounding LLC Terminated
Class II August 14, 2019 STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Herpes-P, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra, CA… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class II August 14, 2019 LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Compounding, 340… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State Street,… Lack of Assurance of Sterility RXQ Compounding LLC Terminated
Class II August 14, 2019 Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies… CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices. Herbal Doctor Remedies Terminated
Class III August 14, 2019 Lovastatin Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and… CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual… American Health Packaging Terminated
Class III August 7, 2019 DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class I August 7, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton… Failed dissolution specifications : failed results at the 3-month stability time point. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II August 7, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, packaged in 5mL… Subpotent Drug ImprimisRx NJ Terminated
Class III August 7, 2019 SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx… Lack of Processing Controls Wise Pharmacy Terminated
Class II August 7, 2019 Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy,… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise… Lack of Processing Controls Wise Pharmacy Terminated
Class II August 7, 2019 Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only,… Subpotent Drug ImprimisRx NJ Terminated
Class III August 7, 2019 CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx… Lack of Processing Controls Wise Pharmacy Terminated
Class II August 7, 2019 Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and… Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long… Lupin Pharmaceuticals Inc. Terminated
Class II August 7, 2019 Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic… CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. H J Harkins Company Inc dba Pharma Pac Terminated
Class III August 7, 2019 ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%),… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class III August 7, 2019 festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and… Lack of Processing Controls Wise Pharmacy Terminated
Class II August 7, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx… Lack of Processing Controls Wise Pharmacy Terminated
Class III August 7, 2019 DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC,… CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. NingBo Huize Commodity Co.,Ltd. Terminated
Class II August 7, 2019 Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5… Lack of Processing Controls Wise Pharmacy Terminated
Class II August 7, 2019 Gablofen Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box… Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an… Piramal Critical Care, Inc. Terminated
Class II August 7, 2019 Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12… Microbial contamination of non-sterile product LNK International, Inc. Terminated
Class II August 7, 2019 Divalproex sodium DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose… cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. MAJOR PHARMACEUTICALS Terminated
Class II August 7, 2019 Doxycycline Hyclate Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose… Failed Dissolution Specifications: Out of specification result for the dissolution test. American Health Packaging Terminated
Class II July 31, 2019 Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic… CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. Preferred Pharmaceuticals, Inc Terminated
Class II July 31, 2019 Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g)… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen… Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in… Dercher Enterprises, Inc., DBA Gordon Laboratories Terminated
Class II July 31, 2019 ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class III July 31, 2019 Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28… Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets Amneal Pharmaceuticals, Inc. Terminated
Class II July 31, 2019 Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream,… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft &… Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and… La Fresh Group, Inc. Terminated
Class II July 31, 2019 Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar,… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g)… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml),… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL),… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count… Failed Dissolution Specifications Ascend Laboratories LLC Terminated
Class II July 31, 2019 Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40… cGMP Deviations: Products may have microbial contamination. Geritrex, LLC Terminated
Class II July 31, 2019 AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b)… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 Clobazam Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma… Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61>… Bionpharma Inc. Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b)… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b)… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b)… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Temozolomide Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b)… CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Deva Holding AS - Cerkezkoy Subesi Terminated
Class II July 31, 2019 SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class III July 31, 2019 Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only,… Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9… Lupin Pharmaceuticals Inc. Terminated
Class II July 31, 2019 Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for… Failed Dissolution Specifications. Ucb, Inc Terminated
Class II July 31, 2019 GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies,… Pharma-Natural Inc. Terminated
Class II July 31, 2019 Hydrocodone Polistirex and Chlorpheniramine Polistirex Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension,… Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients,… Tris Pharma Inc. Terminated
Class II July 31, 2019 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare… Lack of Assurance of Sterility: Bags have potential to leak. Baxter Healthcare Corporation Terminated
Class II July 31, 2019 Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only,… Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s… Lupin Pharmaceuticals Inc. Terminated
Class III July 24, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL… Labeling: Missing label; Product complaints reported missing bottle label. Lupin Pharmaceuticals Inc. Terminated
Class II July 24, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL,… Lack of Assurance of Sterility: Bags have the potential to leak. Pfizer Inc. Terminated
Class II July 24, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL,… Lack of Assurance of Sterility: Bags have the potential to leak. Pfizer Inc. Terminated
Class I July 24, 2019 Fluorouracil Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx… Presence of Particulate Matter; glass particulates Fresenius Kabi USA, LLC Terminated
Class II July 17, 2019 Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Golden State Medical Supply Inc. Terminated
Class II July 17, 2019 LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Teva Pharmaceuticals USA Ongoing
Class II July 17, 2019 LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Teva Pharmaceuticals USA Ongoing
Class II July 17, 2019 Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Golden State Medical Supply Inc. Terminated
Class II July 17, 2019 Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Golden State Medical Supply Inc. Terminated
Class II July 17, 2019 Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Golden State Medical Supply Inc. Terminated
Class II July 17, 2019 Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product… MAJOR PHARMACEUTICALS Terminated
Class II July 17, 2019 PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial,… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First… Lack of Assurance of Sterility. First Pharma Associates LLC dba Riverpoint Pharmacy Terminated
Class II July 17, 2019 Losartan Potassium Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Macleods Pharma Usa Inc Terminated
Class II July 17, 2019 Anastrozole Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC… GMP Deviations: Potential cross contamination due to cleaning procedure failure. American Health Packaging Terminated
Class II July 17, 2019 Losartan Potassium Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Macleods Pharma Usa Inc Terminated
Class II July 17, 2019 losartan potassium and hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Macleods Pharma Usa Inc Terminated
Class II July 17, 2019 losartan potassium and hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Macleods Pharma Usa Inc Terminated
Class II July 17, 2019 losartan potassium and hydrochlorothiazide Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only,… CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical… Macleods Pharma Usa Inc Terminated
Class III July 10, 2019 Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count… Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. Amneal Pharmaceuticals, Inc. Terminated
Class I July 10, 2019 Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe,… Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite… PharMEDium Services, LLC Terminated
Class III July 10, 2019 Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles,… Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets. Amneal Pharmaceuticals, Inc. Terminated
Class III July 10, 2019 Testosterone Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation… Defective Container; actuator may improperly function and affect dose delivery. InvaGen Pharmaceuticals, Inc. Terminated
Class II July 3, 2019 Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only,… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only,… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma,… Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia)… H J Harkins Company Inc dba Pharma Pac Terminated
Class II July 3, 2019 SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only,… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx… GMP Deviations; possible cross contamination of product due to cleaning procedure failure. American Health Packaging Terminated
Class II July 3, 2019 Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card),… GMP Deviations; possible cross contamination of product due to cleaning procedure failure. American Health Packaging Terminated
Class II July 3, 2019 SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only,… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy… Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination… Premier Pharmacy Labs Inc Terminated
Class II July 3, 2019 Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent… Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia)… H J Harkins Company Inc dba Pharma Pac Terminated