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
D-0446-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7788 syringes
- Official record key
drug-enforcement:D-0446-2022
Official wording
Reason: CGMP Deviations
Code information: 08-2021-02@9 12-15-2021, 08-2021-16@10 12-29-2021, 09-2021-08@6 01-21-2022, 09-2021-20@6 02-02-2022 & 10-2021-18@6 03-02-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations