Proctofoam Topical Aerosol Recalled for cGMP Manufacturing Deficiencies
Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol due to current Good Manufacturing Practice (cGMP) deficiencies. The recall affects 233,199 10-gram aerosol containers distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a prescription drug due to cGMP deficiencies. The source text does not report any illnesses, injuries, or deaths. Class II recalls without reported harm typically fall in the Moderate range, as they reflect manufacturing control issues rather than imminent safety threats.
Plain-English summary
Mylan Pharmaceuticals Inc is voluntarily recalling Proctofoam HC, a prescription topical aerosol used to treat rectal discomfort, due to current Good Manufacturing Practice (cGMP) deficiencies identified during manufacturing operations. The recalled product contains hydrocortisone acetate 1% and pramoxine hydrochloride 1% and is distributed by Meda Pharmaceuticals Inc.
A total of 233,199 10-gram aerosol containers were distributed nationwide in the United States. The affected lots are: Lot 32925 (expiration May 2023), Lot 33010 (expiration June 2023), and Lots 33119 and 33123 (expiration August 2023). NDC number 0037-6822-10.
Consumers should stop using the product and contact their healthcare provider or pharmacist for alternative treatment options. The recall was initiated on January 21, 2022, and voluntarily initiated by the firm via letter notification.
The recalled product
- Product
- PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
- Brand
- PROCTOFOAM
- Manufacturer
- Mylan Pharmaceuticals Inc
- Hazard
- cgmp-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: 32925
- Exp. date May 2023
- 33010
- Exp. date June 2023
- 33119
- 33123
- Exp. date August 2023
Distribution
Distributed nationwide across the United States.
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