Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 2...
FDA Recall #D-0419-2019 — Class II — December 17, 2018
Product Description
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
Reason for Recall
Lack of Processing Controls.
Recalling Firm
Duren Health Mart Pharmacy — Waynesboro, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
876 cc
Distribution
TN only
Code Information
N/A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated