Losartan Potassium Tablets recall: Impurity Out of Spec
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta)…
Why was Losartan Potassium Tablets 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?
Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020
- Product
- LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta)…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- N/A
- Distribution
- Bulk product was distributed to one re-packager in California.
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)