Class I - Dangerous
Marketed Without an Approved NDA/ANDA
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
Amerisource Health Services
Class I - Dangerous
Presence of Foreign Tablets/Capsules.
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.
West-Ward Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Amneal Pharmaceuticals
Class I - Dangerous
Presence of Particulate Matter
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert.
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Allergan Sales
Class I - Dangerous
Failed Impurities/Degradation Specifications.
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01
Amerisource Health Services
Class I - Dangerous
Failed Stability Specifications
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Jubilant Cadista Pharmaceuticals
Class I - Dangerous
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class I - Dangerous
Superpotent drug: out of specification result for potency
Class I - Dangerous
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
Dr. Reddy's Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle