Losartan Potassium and Hydrochlorothiazide Tablets recall: Impurity Out of Spec
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536…
Why was Losartan Potassium and Hydrochlorothiazide 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?
BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536…
- Recalling firm
- Macleods Pharma Usa Inc
- Quantity
- 29106 bottles (2,619,540 tablets)
- Distribution
- Nationwide
- Recall date
- July 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)