D-1141-2015 Class II Terminated
FDA drug recall D-1141-2015 was initiated by AstraZeneca Pharmaceuticals LP on June 10, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 27, 2016). Affected quantity: 34,524 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 24, 2015
- Initiation Date
- June 10, 2015
- Termination Date
- September 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,524 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide to wholesalers for further distribution at the retail level.
Code Information
Lot # FC0064; Exp. 05/17