Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265
Summary
The FDA issued a Class II for Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan by MYLAN PHARMACEUTICALS INC. Reason: Failed Dissolution Specifications - low dissolution results.
Details
Source
Drug Recall
External ID
D-0280-2025
Action Date
2025-03-26
Status
Ongoing
Category
drug
Product Description
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Lot/Code Info: Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
Quantity Affected: N/A
Reason for Recall
Failed Dissolution Specifications - low dissolution results
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-25
Company
Morgantown, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
MYLAN PHARMACEUTICALS INC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MYLAN PHARMACEUTICALS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MYLAN PHARMACEUTICALS INC have FDA actions?
MYLAN PHARMACEUTICALS INC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0280-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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