Class II
Terminated
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- June 20, 2019
- Posted
- July 17, 2019
- Recall Number
- D-1458-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4277 bottles (4,277,000 tablets)
- Firm Location
- Plainsboro, NJ, United States
Reason for Recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Distribution
Nationwide
Lot / Code Info
BLI710A Nov 2019
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