April 2022 FDA Recall Pantoprazole Sodium by Torrent Pharma Inc
D-0852-2022 - CGMP deviations
This Class II drug recall was voluntarily initiated by Torrent Pharma Inc on April 11, 2022 for the product Pantoprazole Sodium. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0852-2022
CGMP deviations: tablets cracking
04-11-2022
05-11-2022
24,888 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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Torrent Pharma 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.
Nationwide in the U.S.A
07-25-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.
Batch or Lot Expiration Information
Lot# s: BA34G021, BA34G022, Exp. 09/2022
