FDA recall D-0446-2022
Edge Pharma, LLC · Class II · drug
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
Distribution
nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-06
- Report date
- 2022-02-02
- Termination date
- 2023-06-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Colchester, VT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2022