Why it was recalled
CGMP Deviations: Discoloration
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: PAN22542, Exp. Date: 9/2024
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0530-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 14, 2023
- FDA report date
- Apr 19, 2023
- Quantity
- 2,352 bottles
- Recall type
- N/A
- Recalling firm
- Hetero USA Inc
Original FDA data
Every field from FDA enforcement report D-0530-2023, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91855
- Address
- 1035 Centennial Ave
- Code information
- Lot #: PAN22542, Exp. Date: 9/2024
- Postal code
- 08854-4124
- Report date
- Apr 19, 2023
- Product type
- Drugs
- Recall number
- D-0530-2023
- Classification
- Class II
- Recalling firm
- Hetero USA Inc
- Product quantity
- 2,352 bottles
- Reason for recall
- CGMP Deviations: Discoloration
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 14, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2023