D-0333-2019 Class II Terminated
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