D-0040-2017 Class II Terminated
FDA drug recall D-0040-2017 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: 1561 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
- 1561 syringes
Product Description
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
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: 15103037M, 15117042M, 15126027M, 15127049M, 15131003M, 15119043M, 15138050M, 15141033M, 15142056M, 15146040M, 15149039M, 151890299M, 151900220M, 151930019M, 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-0040-2017
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026