Drug recall D-0833-2022
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots and codes
Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 15, 2022
- Terminated
- October 13, 2023
Related products
- Losartan potassium – drug information
- NDC 33342-045 Losartan potassium · Losartan Potassium 50 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-044 Losartan potassium · Losartan Potassium 25 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-046 Losartan potassium · Losartan Potassium 100 mg/1 · Macleods Pharmaceuticals Limited