Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0. |
|---|---|
| Recall Number | D-1410-2012 |
| Classification | Class III |
| Code Info | Lot #: H008328, Exp 11/14 |
| Product Distributed Qty | 2,556 bottles |
| Reason For Recall | Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules. |
Event Detail
| Event Id | 62439 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | ASTRA ZENECA Lp |
| City | WILMINGTON |
| State | DE | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide. |
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