Home / Recalls / Pharmedium Services, LLC / D-1358-2015

D-1358-2015 Class I Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1358-2015 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: 264 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: 264 bags

Product Description

EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.

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 #: 15033030S, 15033031S, Exp 04/26/15; 15026051S, Exp 05/03/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1358-2015
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.

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