Drug 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.
D-0852-2022
Product summary
- Event
- Event 89992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,888 bottles
- Official record key
drug-enforcement:D-0852-2022
Official wording
Reason: CGMP deviations: tablets cracking
Code information: Lot #s: BA34G021, BA34G022, Exp. 09/2022
Distribution pattern: Nationwide in the U.S.A
Derived failure modes
-
Manufacturing or process control
CGMP deviations