Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for ...
FDA Recall #D-0446-2022 — Class II — December 6, 2021
Product Description
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
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7788 syringes
Distribution
nationwide
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated