Mylan Pharmaceuticals Inc. is recalling 233,199 containers of Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol. The recall was initiated due to manufacturing deficiencies that violate Current Good Manufacturing Practice (cGMP) standards. No injuries or incidents have been reported to date.
Deficiencies in manufacturing processes can lead to concerns regarding the quality, purity, and potency of the medication. While no specific adverse events have been reported, the medication may not meet required safety and effectiveness standards.
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Distributed by Meda Pharmaceuticals Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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