Losartan Potassium Tablets recall: Impurity Out of Spec
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods…
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?
Review the official FDA enforcement record for current 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?
BLI711A Nov 2019
- Product
- Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods…
- Recalling firm
- Macleods Pharma Usa Inc
- Quantity
- 47520 bottles (4,276,800 tablets)
- Distribution
- Nationwide
- Recall date
- July 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)