Home / Recalls / Pharmedium Services, LLC / D-1415-2016

D-1415-2016 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1415-2016 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: 1,470 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: 1,470 bags

Product Description

3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), 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 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 ; Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 ; Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 ; Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 ; Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 ; Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 ; Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 ; Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 ; Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 ; Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 ; Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 ; Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 ; Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 ; Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 ; Service Code 2K8284 , Lot Number 160520118M , Exp. Date 5/22/2016 ; Service Code 2K8284 , Lot Number 160610207M , Exp. Date 5/31/2016 ; Service Code 2K8284 , Lot Number 160620153M , Exp. Date 6/1/2016 ; Service Code 2K8284 , Lot Number 160750236M , Exp. Date 6/14/2016 ; Service Code 2K8284 , Lot Number 160770226M , Exp. Date 6/16/2016 ; Service Code 2K8284 , Lot Number 160840209M , Exp. Date 6/23/2016 ; Service Code 2K8284 , Lot Number 160910218M , Exp. Date 6/30/2016 ; Service Code 2K8284 , Lot Number 160960157M , Exp. Date 7/5/2016 ; Service Code 2K8284 , Lot Number 161080227M , Exp. Date 7/17/2016 ;

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1415-2016
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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