Status
Terminated
Drug Enforcement 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.
Classification
Class III
Report Date
July 18, 2012
Termination Date
April 11, 2013
Product Information
- 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.
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- ASTRA ZENECA Lp
- Address
-
1800 CONCORD PIKE
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1410-2012
- Event ID
- 62439
- Recall initiation date
- July 2, 2012
- Center classification date
- July 11, 2012
- Code info
- Lot #: H008328, Exp 11/14
- More code info
- —