Mylan Pharmaceuticals Inc: Drug Recall

Recall #D-0452-2022 · 01/21/2022

Class II: Risk

Recall Details

Recall Number: D-0452-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Mylan Pharmaceuticals Inc
Status: Terminated
Date Initiated: 01/21/2022
Location: Morgantown, WV, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 233,199/10 g aerosol containers

Reason for Recall

cGMP deficiencies

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.

Distribution Pattern

Recalled product was distributed nationwide within the United States.

Other Recalls by Mylan Pharmaceuticals Inc

Class II: Risk 02/25/2025

Failed Dissolution Specifications - low dissolution results
Class I: Dangerous 07/05/2022

Labeling: Missing label: Label missing from some prefilled pens.
Class I: Dangerous 04/12/2022

Labeling: Missing label on the vial
Class II: Risk 04/07/2022

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II: Risk 04/01/2022

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.

View all recalls by Mylan Pharmaceuticals Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.