D-0032-2017 Class II Terminated
FDA drug recall D-0032-2017 was initiated by Pharmedium Services, LLC on Jul 17, 2015 and is designated Class II. Reason for recall: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. The recall status is terminated (terminated Jun 23, 2017). Affected quantity: 210 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 19, 2016
- Initiation Date
- Jul 17, 2015
- Termination Date
- Jun 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 210 syringes
Product Description
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
Reason for Recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 151000045M, 15127040M, 15133026M, 15141029M, 151930078M, 15132103M, Exp between 07/15/15-10/12/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0032-2017
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026