REGULATORY INTELLIGENCE·Warning Letter
H & H Remedies' Vapor Ointment Recall Highlights Enduring CGMP Compliance Risks for OTC Manufacturers
H & H Remedies, LLC's Class II recall of Vapor Ointment due to CGMP deviations underscores persistent quality control challenges in the OTC sector. Procurement and regulatory teams must enhance supplier qualification and audit programs to mitigate risks, ensuring product integrity and uninterrupted supply. This event, terminated in May 2024, serves as a critical reminder for vigilance.
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