PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Reported: June 1, 2022 Initiated: May 3, 2022 #D-0891-2022

Product Description

Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Details

Units Affected
31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).
Distribution
Within the U.S in FL and CA.
Location
Anaheim, CA

Frequently Asked Questions

What product was recalled?
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: 31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E)..
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 June 1, 2022. Severity: Moderate. Recall number: D-0891-2022.