May 2022 FDA Recall Drug by Remedyrepack Inc.
D-0885-2022 - CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on May 4, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations- azido impurity levels observed to be above acceptable limits. The product was distributed in Recalled product was distributed to Florida. and the recall is currently terminated.

Recall Number: D-0885-2022

Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Initiated
05-04-2022
Reported
06-01-2022
Quantity
22 bottles/90 count each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90134
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalled product was distributed to Florida.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-02-2022
Product Description About Product Description
Full technical description of the product.
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00

Batch or Lot Expiration Information

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