Multi-event August 2018 FDA Recall Drug by Remedyrepack Inc.
This Multi-event Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 10, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to three customers in FL and VA. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1100-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
08-10-2018
08-22-2018
9 bottles of 90 = 810 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 three customers in FL and VA.
10-12-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
Batch or Lot Expiration Information
Lot# B0335344-081717, exp. date 08/2018
Lot# B0363364-110917, exp. date 11/2018
Lot# B0391225-012218, exp. date 01/2019
Lot# B0408458-030618, exp. date 03/2019
Lot# B0384871-010318, exp. date 01/2019
Lot# B0436862-051518, exp. date 05/2019
Recall Number: D-1101-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
08-10-2018
08-22-2018
21 bottles of 90 = 1890 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 three customers in FL and VA.
10-12-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
Batch or Lot Expiration Information
Lot# B0335344-081717, exp. date 08/2018
Lot# B0363364-110917, exp. date 11/2018
Lot# B0391225-012218, exp. date 01/2019
Lot# B0408458-030618, exp. date 03/2019
Lot# B0384871-010318, exp. date 01/2019
Lot# B0436862-051518, exp. date 05/2019
Recall Number: D-1102-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
08-10-2018
08-22-2018
36 bottles of 90 = 3240 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 three customers in FL and VA.
10-12-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
Batch or Lot Expiration Information
Lot# B0362988-110917, exp. date 10/2018
Lot# B0432265-050318, exp. date 05/2019
Lot# B0450321-061218, exp. date 06/2019
Lot# B0450322-061218, exp. date 05/2019
Lot# B0408652-030718, exp. date 02/2019
