Piscataway, NJ, United States
Hetero USA Inc recalls
1 recall recorded since 2018, most recently on 14 March 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 14 March 2023
- Reason
- CGMP Deviations: Discoloration
- Distribution
- Nationwide within the United States
- Initiated
- N/A
- Recall number
- D-0530-2023
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.