Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Reported: November 6, 2019 Initiated: October 18, 2019 #D-0155-2020
Product Description
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Reason for Recall
Failed Dissolution Specification: Low out of specification dissolution results.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 4,272 bottles
- Distribution
- Nationwide within the United States
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 4,272 bottles.
Why was this product recalled? ▼
Failed Dissolution Specification: Low out of specification dissolution results.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2019. Severity: Moderate. Recall number: D-0155-2020.
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