LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles recall: Impurity Out of Spec
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Why was LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles recalled?
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
- Product
- LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 2,943,000 tablets
- Distribution
- Nationwide by 4 major distributors.
- Recall date
- July 17, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)