July 2012 FDA Recall Nexium by Astra Zeneca Lp
D-1410-2012 - Adulterated Presence of Foreign Tablets/Capsules
This Class III drug recall was voluntarily initiated by Astra Zeneca Lp on July 2, 2012 for the product Nexium. The FDA reported the reason for recall as adulterated presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1410-2012
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.
07-02-2012
07-18-2012
2,556 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
ASTRA ZENECA Lp
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
04-11-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
