Drug product
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
D-1141-2015
Product summary
- Event
- Event 71483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,524 bottles
- Official record key
drug-enforcement:D-1141-2015
Official wording
Reason: Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Code information: Lot # FC0064; Exp. 05/17
Distribution pattern: Nationwide to wholesalers for further distribution at the retail level.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets