January 2017 FDA Recall Mirtazapine by Mylan Pharmaceuticals Inc.
D-0492-2017 - Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on January 19, 2017 for the product Mirtazapine. The FDA reported the reason for recall as presence of foreign tablets/capsules; possibility of glipizide 10 mg tablet in bottle. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0492-2017
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
01-19-2017
03-15-2017
37,445 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.
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.
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Batch or Lot Expiration Information
Lot# a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019
