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U.S. Department of Health and Human Services

Enforcement Report - Week of June 24, 2015

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Product Detail

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.
Recall Number D-1141-2015
Classification Class II
Code Info Lot # FC0064; Exp. 05/17
Product Distributed Qty 34,524 bottles
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.

Event Detail

Event Id 71483
Product Type Drugs
Status Ongoing
Recalling Firm AstraZeneca Pharmaceuticals LP
City Wilmington
State DE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-06-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide to wholesalers for further distribution at the retail level.