June 2012 FDA Recall Tacrolimus by Mylan Llc.
D-066-2013 - Failed USP Content Uniformity Requirements
This Class II drug recall was voluntarily initiated by Mylan Llc. on June 29, 2012 for the product Tacrolimus. The FDA reported the reason for recall as failed usp content uniformity requirements. The product was distributed in Natiowide and the recall is currently terminated.
Recall Number: D-066-2013
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
06-29-2012
12-05-2012
15181 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 LLC.
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.
Natiowide
04-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Batch or Lot Expiration Information
Lot# Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
