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
Reported: April 19, 2023 Initiated: March 14, 2023 #D-0530-2023
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
Reason for Recall
CGMP Deviations: Discoloration
Details
- Recalling Firm
- Hetero USA Inc
- Units Affected
- 2,352 bottles
- Distribution
- Nationwide within the United States
- Location
- Piscataway, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero USA Inc. Units affected: 2,352 bottles.
Why was this product recalled? ▼
CGMP Deviations: Discoloration
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 19, 2023. Severity: Moderate. Recall number: D-0530-2023.
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