Edge Pharma, LLC recalls Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge
Recalled February 2, 2022 · FDA recall D-0446-2022 · Edge Pharma
Hazard
CGMP Deviations · FDA Class II
Units
7788 syringes
Sold at
nationwide
Description
CGMP Deviations
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
Manufacturer(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →