Multi-event April 2022 FDA Recall Zonisamide by Glenmark Pharmaceuticals Inc., Usa
This Multi-event Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on April 25, 2022 for the product Zonisamide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.
Reported Recall Events
Recall Number: D-0792-2022
cGMP deviations
04-25-2022
05-04-2022
12,003 bottles
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
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.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
Batch or Lot Expiration Information
Lot# : 29200064, Exp 5/31/2023
Affected Packages Involved in this Recall
Recall Number: D-0793-2022
cGMP deviations
04-25-2022
05-04-2022
a) 7,044 bottles; b) 1,014 bottles
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
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.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Batch or Lot Expiration Information
Lot# a)
Lot# : 29200053, Exp 4/30/2023; b)
Lot# : 29200054, Exp 4/30/2023
Affected Packages Involved in this Recall
Recall Number: D-0791-2022
cGMP deviations
04-25-2022
05-04-2022
11,136 bottles
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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
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.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Batch or Lot Expiration Information
Lot# : 29200052, Exp 4/30/2023
