D-0041-2017 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0041-2017 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: 616 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
616 syringes

Product Description

fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.

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: 15103031M, 15127041M, 15139034M, 15140039M, 15141048M, 15147057M, 15147086M, 15148053M, 151880285M, 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-0041-2017
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.