Recalls / Class II
Class IID-1141-2015
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.
- Affected lot / code info
- Lot # FC0064; Exp. 05/17
Why it was recalled
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.
Recalling firm
- Firm
- AstraZeneca Pharmaceuticals LP
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1800 Concord Pike, Wilmington, Delaware 19850
Distribution
- Quantity
- 34,524 bottles
- Distribution pattern
- Nationwide to wholesalers for further distribution at the retail level.
Timeline
- Recall initiated
- 2015-06-10
- FDA classified
- 2015-06-18
- Posted by FDA
- 2015-06-24
- Terminated
- 2016-09-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1141-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.