D-1357-2015 Class I Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1357-2015 was initiated by Pharmedium Services, LLC on Apr 13, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the… The recall status is terminated (terminated Jan 23, 2017). Affected quantity: 240 bags.

Recall Details

Product Type
Drugs
Report Date
Sep 2, 2015
Initiation Date
Apr 13, 2015
Termination Date
Jan 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
240 bags

Product Description

HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02.

Reason for Recall

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Distribution Pattern

Nationwide

Code Information

Lot #: 15041038S, Exp 04/16/15

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1357-2015
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.