January 2022 FDA Recall Proctofoam by Mylan Pharmaceuticals Inc
D-0452-2022 - cGMP deficiencies

This Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc on January 21, 2022 for the product Proctofoam. The FDA reported the reason for recall as cgmp deficiencies. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0452-2022

Reason for Recall
cGMP deficiencies
Initiated
01-21-2022
Reported
02-02-2022
Quantity
233,199/10 g aerosol containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89415
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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.
Recalled product was distributed nationwide within the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-12-2024
Product Description About Product Description
Full technical description of the product.
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.

Batch or Lot Expiration Information

Lot# : 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023

Affected Packages Involved in this Recall

0037-6822-10 Proctofoam Hc