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.
D-1410-2012
Product summary
- Firm
- ASTRA ZENECA Lp
- Event
- Event 62439
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,556 bottles
- Official record key
drug-enforcement:D-1410-2012
Official wording
Reason: 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.
Code information: Lot #: H008328, Exp 11/14
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets