Drug product
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
D-1256-2020
Product summary
- Event
- Event 85557
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1752 bottles
- Official record key
drug-enforcement:D-1256-2020
Official wording
Reason: Discoloration: product contains brown pellets
Code information: Lot #: C900642, Exp. 06/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Discoloration: product contains brown pellets