Recalls / Class II
Class IID-0834-2022
Product
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 33342-044, 33342-045, 33342-046
- FDA application
- ANDA202230
- Affected lot / code info
- Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
- Distribution pattern
- Product was distributed nationwide.
Timeline
- Recall initiated
- 2022-04-15
- FDA classified
- 2022-05-03
- Posted by FDA
- 2022-05-11
- Terminated
- 2023-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0834-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.