REGULATORY INTELLIGENCE·Warning Letter
Nephron SC, LLC Initiates Class II Recall of Albuterol Sulfate Inhalation Solution Due to Illegible Labeling
Nephron SC, LLC has initiated a Class II recall of 146,280 vials of Albuterol Sulfate Inhalation Solution due to illegible labels. This voluntary, firm-initiated action for lot AB6001, distributed nationwide, underscores critical quality control failures at the 503B outsourcing facility, posing significant supply chain and patient safety risks for procurement and regulatory teams.
90-Day Activity
Nephron SC, LLCAlbuterol SulfateHSN 3004.90
RMRohan Mehta· Senior Supply Chain Intelligence Analyst2026-04-22