October 2019 FDA Recall Prasugrel by Mylan Pharmaceuticals Inc.
D-0155-2020 - Failed Dissolution Specification
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on October 18, 2019 for the product Prasugrel. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0155-2020
Failed Dissolution Specification: Low out of specification dissolution results.
10-18-2019
11-06-2019
4,272 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Batch or Lot Expiration Information
Lot# : 3089793, Exp. Date September 2020
