Home / Recalls / Pharmedium Services, LLC / D-1414-2016

D-1414-2016 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1414-2016 was initiated by Pharmedium Services, LLC on May 5, 2016 and is designated Class II. Reason for recall: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. The recall status is terminated (terminated Mar 6, 2018). Affected quantity: 345 bags.

Recall Details

Product Type: Drugs
Report Date: Jul 27, 2016
Initiation Date: May 5, 2016
Termination Date: Mar 6, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 345 bags

Product Description

3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Reason for Recall

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Distribution Pattern

Nationwide

Code Information

Service Code 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 ; Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 ; Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 ; Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 ; Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 ; Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 ; Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 ; Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 ; Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 ; Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 ; Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 ; Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 ; Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 ; Service Code 2K8180 , Lot Number 160940033C , Exp. Date 6/27/2016 ; Service Code 2K8180 , Lot Number 160970035C , Exp. Date 6/30/2016 ; Service Code 2K8905 , Lot Number 160810187M , Exp. Date 6/11/2016 ; Service Code 2K8905 , Lot Number 160890186M , Exp. Date 6/18/2016 ; Service Code 2K8975 , Lot Number 160550132M , Exp. Date 5/15/2016 ; Service Code 2K8975 , Lot Number 160610229M , Exp. Date 5/22/2016 ; Service Code 2K8975 , Lot Number 160770165M , Exp. Date 6/7/2016 ;

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1414-2016
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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