Why it was recalled
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Product description
NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
Lot numbers, UPCs & expiration codes
Lot # FC0064; Exp. 05/17
Where it was sold
Nationwide to wholesalers for further distribution at the retail level.
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-1141-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2015
- FDA report date
- Jun 24, 2015
- Quantity
- 34,524 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca Pharmaceuticals LP
Original FDA data
Every field from FDA enforcement report D-1141-2015, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 71483
- Address
- 1800 Concord Pike
- Code information
- Lot # FC0064; Exp. 05/17
- Postal code
- 19850
- Report date
- Jun 24, 2015
- Product type
- Drugs
- Recall number
- D-1141-2015
- Classification
- Class II
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Product quantity
- 34,524 bottles
- Termination date
- Sep 27, 2016
- Reason for recall
- Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NEXIUM¿ (esomeprazole magnesium), Delayed-Release capsules, 20 mg, 30-count bottle, Rx only, Manufactured for AstraZeneca LLC, Wilmington, Distributed by AstraZeneca, AB, Sodertalje, Sweden. NDC 00186-5020-31.
- Distribution pattern
- Nationwide to wholesalers for further distribution at the retail level.
- Recall initiation date
- Jun 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2015