Nexium Granule, Delayed Release
FDA Recall NDC 0186-4050
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nexium (NDC 0186-4050). A significant event, classified as Class III, was initiated on Jul 02, 2012 by Astrazeneca Pharmaceuticals Lp. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
July 2012 Class III Recall: Adulterated Presence of Foreign Tablets/Capsules
Recall Number
Class III Terminated
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.
Jul 02, 2012
Jul 18, 2012
2,556 bottles
Recall Profile & Regulatory Data
Event ID
62439
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
ASTRA ZENECA Lp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Apr 11, 2013
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.
Batch or Lot Expiration Information
Lot# : H008328, Exp 11/14
Affected Packages Involved in this Recall
0186-5020-31Product
0186-5020-54Product
0186-5020-82Product
0186-4010-01Product
0186-4010-02Product
0186-4020-01Product
0186-4040-01Product
0186-4040-02Product
0186-5040-31Product
0186-5040-35Product
0186-5040-55Product
0186-5040-85Product
0186-5040-54Product
0186-5040-82Product
0186-5040-05Product
0186-4025-01Product
0186-4025-02Product
0186-4050-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
