Recalls / Class II
Class IID-0852-2022
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.
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Oral
- NDCs
- 13668-096, 13668-429
- FDA application
- ANDA090074
- Affected lot / code info
- Lot #s: BA34G021, BA34G022, Exp. 09/2022
Why it was recalled
CGMP deviations: tablets cracking
Recalling firm
- Firm
- Torrent Pharma Inc
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2091 Hartel Ave, N/A, Levittown, Pennsylvania 19057-4506
Distribution
- Quantity
- 24,888 bottles
- Distribution pattern
- Nationwide in the U.S.A
Timeline
- Recall initiated
- 2022-04-11
- FDA classified
- 2022-05-05
- Posted by FDA
- 2022-05-11
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0852-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.