Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot #: H008328, Exp 11/14
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1410-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 2, 2012
- FDA report date
- Jul 18, 2012
- Quantity
- 2,556 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ASTRA ZENECA Lp
Original FDA data
Every field from FDA enforcement report D-1410-2012, exactly as published.
Show all FDA fields
- City
- WILMINGTON
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 62439
- Address
- 1800 CONCORD PIKE
- Code information
- Lot #: H008328, Exp 11/14
- Postal code
- 19803-2902
- Report date
- Jul 18, 2012
- Product type
- Drugs
- Recall number
- D-1410-2012
- Classification
- Class III
- Recalling firm
- ASTRA ZENECA Lp
- Product quantity
- 2,556 bottles
- Termination date
- Apr 11, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 2, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2012