Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMETHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMETHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIM.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIMB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIM.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIM.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIM.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIL-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IILEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIHydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIHCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass II1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass II1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIGLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIGLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIGENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass IIALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugWell Care Compounding PharmacyClass II17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
- 2016-06-15FDA-DrugBayer Health Care LLCClass IICoppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Labeling; Product Contains Undeclared API (Oxybenzone)
- 2016-06-15FDA-DrugPharmedium Services, LLCClass IIPotassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
- 2016-06-15FDA-DrugAidarex Pharmaceuticals LLCClass IICHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
- 2016-06-15FDA-DrugAidarex Pharmaceuticals LLCClass IIICEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
- 2016-06-15FDA-DrugNovacare, LLCClass IXcellerator (product not labeled)
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- 2016-06-15FDA-DrugNovacare, LLCClass IMethyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
- 2016-06-15FDA-DrugNovacare, LLCClass IBlack Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
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