Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx O
Summary
The FDA issued a Class II for Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topica by Mylan Pharmaceuticals Inc. Reason: cGMP deficiencies.
Details
Source
Drug Recall
External ID
D-0452-2022
Action Date
2022-02-02
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #: 32925, Exp. date May 2023, 33010, Exp. date June 2023; 33119, 33123, Exp. date August 2023
Quantity Affected: 233,199/10 g aerosol containers
Reason for Recall
cGMP deficiencies
Distribution
Recalled product was distributed nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-21
Company
Morgantown, WV
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 100 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mylan Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mylan Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mylan Pharmaceuticals Inc have FDA actions?
Mylan Pharmaceuticals Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0452-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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