May 2017 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0920-2017 - Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on May 9, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification results for sulphoxide impurity and total impurities. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0920-2017
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
05-09-2017
06-21-2017
11,624 pouches
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.
Nationwide
02-14-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Batch or Lot Expiration Information
Batch# Batch 3074707, exp 02/2018
