Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9...
FDA Recall #D-0333-2019 — Class II — December 5, 2018
Product Description
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Reason for Recall
Sub-potent
Recalling Firm
Pharmedium Services, LLC — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
295 50 ml in 60 ml syringes
Distribution
Nationwide in the USA.
Code Information
Lot: 183220013C Exp. 12/19/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated