Drug product
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
D-0995-2019
Product summary
- Event
- Event 82065
- Status
- Terminated
- Classification
- Class III
- Quantity
- 40,592, 90 and 1,000 count bottles
- Official record key
drug-enforcement:D-0995-2019
Official wording
Reason: Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Code information: Lot #: a) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.