June 2016 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0706-2017 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on June 22, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0706-2017
Failed Dissolution Specifications
06-22-2016
05-31-2017
24,176 bottles (1,450,560 tablets)
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-12-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Batch or Lot Expiration Information
Lot# Code: 0378-5022-91 Lot: 3065878; Exp. 04/17
