REGULATORY INTELLIGENCE·Recall
Seaway Pharma Inc. Initiates Class II Recall for Oxymetazoline Hydrochloride Nasal Spray Over CGMP Deviations
Seaway Pharma Inc. has initiated a Class II recall for 7,992 bottles of Oxymetazoline hydrochloride 0.05% nasal spray due to potential microbial contamination in manufacturing water. While final products tested clean, this CGMP deviation highlights critical quality control risks for procurement and regulatory teams. Supply chain VPs should assess exposure in Michigan and Pennsylvania, while business development executives note the ongoing FDA scrutiny on manufacturing processes across the OTC drug sector.
90-Day Activity
Seaway PharmaOxymetazoline HydrochlorideHSN 3004.90
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2024-01-10