RecallCheckr

Teva Pharmaceuticals USA Inc recalls

8 recalls on record · 1 rated Critical · 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.

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Health Serious

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva…

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Teva Pharmaceuticals USA Inc Jul 19, 2023
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Health Moderate

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets…

Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc May 31, 2023
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Health Moderate

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets,…

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

Teva Pharmaceuticals USA Inc Apr 12, 2023
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Health Serious

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA…

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

Teva Pharmaceuticals USA Inc Sep 7, 2022
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Health Moderate

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By:…

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Teva Pharmaceuticals USA Inc Aug 17, 2022
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Health Serious

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30…

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Teva Pharmaceuticals USA Inc Aug 3, 2022
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Health Moderate

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only,…

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Teva Pharmaceuticals USA Inc Jun 15, 2022
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Health Critical

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single…

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Teva Pharmaceuticals USA Inc Apr 20, 2022
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