Class II
Terminated
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 Pharma USA, Inc. Plainsboro, NJ 08536
This recall has been terminated (originally issued May 11, 2022).
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- April 15, 2022
- Posted
- May 11, 2022
- Recall Number
- D-0832-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
- Firm Location
- Plainsboro, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution
Product was distributed nationwide.
Lot / Code Info
Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022
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