March 2020 FDA Recall Tacrolimus by Mylan Pharmaceuticals Inc.
D-1057-2020 - Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on March 23, 2020 for the product Tacrolimus. The FDA reported the reason for recall as presence of foreign tablet/capsule - potential presence of commingled one tacrolimus 1 mg capsule in 5 mg bottles.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1057-2020

Reason for Recall
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Initiated
03-23-2020
Reported
04-01-2020
Quantity
3,816 botlles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85273
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-07-2021
Product Description About Product Description
Full technical description of the product.
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

Batch or Lot Expiration Information

Lot# 3105410, 3106268, Exp 9/2020

Affected Packages Involved in this Recall

0378-2045-01 Tacrolimus
0378-2046-01 Tacrolimus
0378-2047-01 Tacrolimus