PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09

Reported: June 1, 2022 Initiated: May 2, 2022 #D-0887-2022

Product Description

Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09

Reason for Recall

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

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
30 bottles/90 count = 2,700 tablets
Distribution
Product was distributed to FL, SC and VA
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09. Recalled by RemedyRepack Inc.. Units affected: 30 bottles/90 count = 2,700 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 June 1, 2022. Severity: Moderate. Recall number: D-0887-2022.