Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL,…
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Read the official notice →- Date
- 2023-03-15
- Country
- United States
- Brand
- Teva Pharmaceuticals
- Product
- Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort…
- Classification
- Class II
- Units
- CA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Teva Pharmaceuticals recalls
- 2023-05-31
US
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne…
Labeling: Incorrect or Missing Package Insert
- 2023-04-12
US
Teva Pharmaceuticals USA Inc recalls Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva…
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
- 2023-03-22
US
Teva Pharmaceuticals USA Inc recalls Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL…
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- 2022-09-21
US
Teva Pharmaceuticals USA Inc recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a…
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
- 2022-09-07
US
Teva Pharmaceuticals USA Inc recalls Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA…
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.
- 2022-08-17
US
Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories,…
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Other drugs & medical recalls in the United States
- 2023-03-15
US
Akron Pharma, Inc. recalls DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Labeling: Incorrect or Missing Lot and/or Exp Date
US
US
Denver Solutions, LLC DBA Leiters Health recalls Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796…
CGMP DEVIATIONS
FDA · DrugDenver Solutions, LLC DBA Leiters HealthNationwide within the United States including VA or other Government facilitiesOfficial notice →US
Nutraceutical Corporation recalls NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp.…
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
US
Amerisource Health Services LLC recalls Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by:…
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
US