RecallRadar

FDA Drug recall D-0885-2022

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

On 2022-06-01 the FDA classified a Class II recall of Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00 by Remedyrepack, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0885-2022
ClassificationClass II
Statusterminated
Initiated2022-05-04
Published2022-06-01
Last updated2026-09-13 11:52 UTC
CompanyRemedyrepack
DistributionFL

Product

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

Reason

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

Identifiers

code_infoLot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0885-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.