Product: Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Reason for recall: CGMP Deviations
Recall initiated: 20211206
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated