Recalls / Class II
Class IID-1162-2022
Product
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 72789-163, 72789-164, 72789-165
- FDA application
- ANDA090382
- Affected lot / code info
- Lots: D21D63 Exp. 11/30/22; E21A73 Exp. 11/30/22; E21D35 Exp. 11/30/22; F21A28 Exp. 11/30/22; F21D04 Exp. 09/30/22; G21B03 Exp. 11/30/22; G21E23 Exp. 11/30/22; H21B46 Exp. 11/30/22; H21D46 Exp. 08/31/23; H21D46 Exp. 08/31/23; I21B67 Exp. 01/31/23; J21A26 Exp. 01/31/23; J21C44 Exp. 01/31/23
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 687 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-06-06
- FDA classified
- 2022-06-27
- Posted by FDA
- 2022-07-06
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1162-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.