Home / Recalls / Mylan Pharmaceuticals Inc / D-0452-2022

D-0452-2022 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
February 2, 2022
Initiation Date
January 21, 2022
Termination Date
March 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
233,199/10 g aerosol containers

Product Description

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.

Reason for Recall

cGMP deficiencies

Distribution Pattern

Recalled product was distributed nationwide within the United States.

Code Information

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

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  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)
  • D-1031-2020 Class II — Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceu (March 9, 2020)