D-0789-2022 Class II Terminated
FDA drug recall D-0789-2022 was initiated by Preferred Pharmaceuticals, Inc. on Apr 12, 2022 and is designated Class II. Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. The recall status is terminated (terminated Sep 22, 2022). Affected quantity: 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 12, 2022
- Termination Date
- Sep 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
Product Description
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution Pattern
Nationwide within the U.S to CA, IN and FL.
Code Information
Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0789-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026