D-0852-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- April 11, 2022
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,888 bottles
Product Description
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.
Reason for Recall
CGMP deviations: tablets cracking
Distribution Pattern
Nationwide in the U.S.A
Code Information
Lot #s: BA34G021, BA34G022, Exp. 09/2022