Why it was recalled
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Product description
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
Lot numbers, UPCs & expiration codes
Lot # JB5047, Exp 10/19
Where it was sold
Nationwide in the USA and Puerto Rico to physician offices.
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-0958-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 25, 2017
- FDA report date
- Jul 19, 2017
- Quantity
- 40,368 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca Pharmaceuticals, LP
Original FDA data
Every field from FDA enforcement report D-0958-2017, exactly as published.
Show all FDA fields
- City
- Newark
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 77336
- Address
- 587 Old Baltimore Pike
- Code information
- Lot # JB5047, Exp 10/19
- Postal code
- 19702-1307
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0958-2017
- Classification
- Class I
- Recalling firm
- AstraZeneca Pharmaceuticals, LP
- Product quantity
- 40,368 bottles
- Termination date
- Apr 24, 2018
- Reason for recall
- Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
- Distribution pattern
- Nationwide in the USA and Puerto Rico to physician offices.
- Recall initiation date
- May 25, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 11, 2017