PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

Reported: June 1, 2022 Initiated: May 4, 2022 #D-0885-2022

Product Description

Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

Reason for Recall

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

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
22 bottles/90 count each
Distribution
Recalled product was distributed to Florida.
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00. Recalled by RemedyRepack Inc.. Units affected: 22 bottles/90 count each.
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-0885-2022.