January 2017 FDA Recall Mirtazapine by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) (D-0493-2017 - Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled)
This Class II drug recall was voluntarily initiated by Mylan Institutional, Inc. (d.b.a. Udl Laboratories) on January 27, 2017 for the product Mirtazapine. The FDA reported the reason for recall as presence of foreign tablets/capsules; possibility of glipizide 10 mg tablets commingled. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0493-2017
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
01-27-2017
03-15-2017
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
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 Institutional, Inc. (d.b.a. UDL Laboratories)
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
03-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Batch or Lot Expiration Information
Batch# 3083289; Exp. Date 12/2018
