Recalls / Class II
Class IID-1457-2019
Product
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
- 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
- BLI711A Nov 2019
Why it was 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.
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, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 47520 bottles (4,276,800 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-06-20
- FDA classified
- 2019-07-09
- Posted by FDA
- 2019-07-17
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1457-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.