D-0040-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

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

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