Teva Pharmaceuticals USA, Inc recalls
13 recalls on record · FDA
Every recall we have on record for Teva Pharmaceuticals USA, Inc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4…
CGMP Deviations: use of an unapproved raw material
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4…
CGMP Deviations: use of an unapproved raw material
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg,…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg,…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL,…
Subpotent drug; Clavulanate Potassium component
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS…
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS…
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by…
Presence of foreign tablets/capsules.
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged…
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva…
Superpotent Drug
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, …
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons,…
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by:…
Failed Dissolution Specifications