Multi-event July 2018 FDA Recall Drug by Remedyrepack Inc.
This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on July 17, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 3 medical facilities in Florida. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1021-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-17-2018
08-08-2018
3 HDPE 90-count bottles (270 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 3 medical facilities in Florida.
10-17-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Batch or Lot Expiration Information
Lot# B0383153-122917; Exp. 12/18
Recall Number: D-1020-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-17-2018
08-08-2018
4 HDPE 90-count bottles (360 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 3 medical facilities in Florida.
10-17-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Batch or Lot Expiration Information
Lot# B0318652-070617; Exp. 07/18
