Hetero USA Inc: Drug Recall
Recall #D-0530-2023 · 03/14/2023
Class II: Risk
Recall Details
- Recall Number
- D-0530-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Hetero USA Inc
- Status
- Ongoing
- Date Initiated
- 03/14/2023
- Location
- Piscataway, NJ, United States
- Voluntary/Mandated
- N/A
- 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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.