November 2017 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0230-2018 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on November 3, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0230-2018
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
11-03-2017
01-31-2018
1,414/500 count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Product was distributed nationwide in the USA
06-14-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC: 0378-2009-05
Batch or Lot Expiration Information
Lot# 3077281, EXP 06-2018
