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
Reported: March 14, 2018 Initiated: February 23, 2018 #D-0585-2018
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
Reason for Recall
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Details
- Recalling Firm
- AstraZeneca Pharmaceuticals LP
- Units Affected
- 18056 bottles
- Distribution
- Nationwide
- Location
- Wilmington, DE
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AstraZeneca Pharmaceuticals LP. Units affected: 18056 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Low. Recall number: D-0585-2018.
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