Multi-event May 2022 FDA Recall Drug by Remedyrepack Inc.
This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on May 2, 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 Product was distributed to FL, SC and VA and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0887-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
05-02-2022
06-01-2022
30 bottles/90 count = 2,700 tablets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to FL, SC and VA
09-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Batch or Lot Expiration Information
Lot# B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022
Recall Number: D-0886-2022
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
05-02-2022
06-01-2022
26/90 count bottles = 2,340 tablets
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to FL, SC and VA
09-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
Batch or Lot Expiration Information
Lot# B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022
