PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 26, 2018 Initiated: December 5, 2018 #D-0333-2019

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

Details

Recalling Firm
Pharmedium Services, LLC
Units Affected
295 50 ml in 60 ml syringes
Distribution
Nationwide in the USA.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Pharmedium Services, LLC. Units affected: 295 50 ml in 60 ml syringes.
Why was this product recalled?
Sub-potent
Which agency issued this recall?
This recall was issued by the FDA Drug on December 26, 2018. Severity: Moderate. Recall number: D-0333-2019.