FDA recall D-1410-2012

ASTRA ZENECA Lp · Class III · drug

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.

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.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2012-07-02
Report date: 2012-07-18
Termination date: 2013-04-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: WILMINGTON, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1410-2012