D-0333-2019 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0333-2019 was initiated by Pharmedium Services, LLC on Dec 5, 2018 and is designated Class II. Reason for recall: Sub-potent The recall status is terminated (terminated Oct 2, 2020). Affected quantity: 295 50 ml in 60 ml syringes.

Recall Details

Product Type
Drugs
Report Date
Dec 26, 2018
Initiation Date
Dec 5, 2018
Termination Date
Oct 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
295 50 ml in 60 ml syringes

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

Distribution Pattern

Nationwide in the USA.

Code Information

Lot: 183220013C Exp. 12/19/2018

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0333-2019
openFDA file date
Nov 3, 2026
Loaded by RegDataLab
Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-0333-2019. Report a data issue: hello@regdatalab.com.