Why it was recalled
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Product description
Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
Lot numbers, UPCs & expiration codes
HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018
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-0585-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 23, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 18056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AstraZeneca Pharmaceuticals LP
Original FDA data
Every field from FDA enforcement report D-0585-2018, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 79290
- Address
- 1800 Concord Pike
- Code information
- HN0406 02/2018 JH0341 03/2018 JH0342 03/2018 JH0147 03/2018 JC0391 04/2018 JK0147 04/2018 JL0184 04/2018 JC0402 05/2018
- Postal code
- 19897-0001
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0585-2018
- Classification
- Class III
- Recalling firm
- AstraZeneca Pharmaceuticals LP
- Product quantity
- 18056 bottles
- Termination date
- Feb 26, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2018