Losartan Potassium Tablets recall: Impurity Out of Spec
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods…
Why was Losartan Potassium Tablets recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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?
Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022
- Product
- Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods…
- Recalling firm
- Macleods Pharma Usa Inc
- Quantity
- 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
- Distribution
- Product was distributed nationwide.
- Recall date
- May 11, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)