March 2018 FDA Recall Fabior by Mayne Pharma Inc
D-0616-2018 - Superpotent Drug

This Class III drug recall was voluntarily initiated by Mayne Pharma Inc on March 21, 2018 for the product Fabior. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0616-2018

Reason for Recall
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Initiated
03-21-2018
Reported
04-11-2018
Quantity
3312 cans

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79604
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.
Mayne Pharma 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-11-2020
Product Description About Product Description
Full technical description of the product.
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Batch or Lot Expiration Information

Lot# Lot: MBEB, Exp. 01/31/2019

Affected Packages Involved in this Recall

51862-295-50 Fabior
51862-295-10 Fabior