FDA Recall D-0530-2023
Hetero USA Inc · Piscataway, NJ
Class II Ongoing 1157 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Reason for recall
CGMP Deviations: Discoloration
Recall record
- Recall number
D-0530-2023- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- N/A
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2023-03-14
- Classified by FDA Center
- 2023-04-11
- FDA published
- 2023-04-19
- Recalling firm
- Hetero USA Inc
- Firm location
- Piscataway, NJ
Drug identification
- Brand name(s)
- PANTOPRAZOLE SODIUM
- Generic name(s)
- PANTOPRAZOLE
- Manufacturer(s)
- Camber Pharmaceuticals, Inc.
- NDC(s)
31722-712, 31722-713- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.