PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

Reported: May 4, 2022 Initiated: April 12, 2022 #D-0789-2022

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.

Details

Units Affected
44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
Distribution
Nationwide within the U.S to CA, IN and FL.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets.
Why was this product recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0789-2022.