Product Safety Recalls

Product Recall Tracker

Recall D-0885-2022

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

Recall D-0885-2022 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0885-2022
Event ID90134
DistributionRecalled product was distributed to Florida.
Quantity22 bottles/90 count each
Recall ReasonCGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Drug ClassificationClass II
Drug Code Info20220601
Recall Initiation Date20220504
Report Date20220601
Classification Date20220520
Address625 Kolter Dr Ste 4
Indiana, PA 15701-3571
United States
Recalling FirmRemedyRepack Inc.
Initial Notification Letter
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