D-1422-2016 Class II Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-1422-2016 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: 655 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
655 bags

Product Description

5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,

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 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 160880192M , Exp. Date 6/27/2016 ; Service Code 2K8254 , Lot Number 160890178M , Exp. Date 6/28/2016 ; Service Code 2K8256 , Lot Number 160480195M , Exp. Date 5/12/2016 ; Service Code 2K8256 , Lot Number 160530189M , Exp. Date 5/17/2016 ; Service Code 2K8256 , Lot Number 160560081M , Exp. Date 5/19/2016 ; Service Code 2K8256 , Lot Number 160590069M , Exp. Date 5/23/2016 ; Service Code 2K8256 , Lot Number 160660151M , Exp. Date 5/30/2016 ; Service Code 2K8256 , Lot Number 160680250M , Exp. Date 6/1/2016 ; Service Code 2K8256 , Lot Number 160880025M , Exp. Date 6/20/2016 ; Service Code 2K8256 , Lot Number 160950047M , Exp. Date 6/27/2016 ;

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1422-2016
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.