Recalls / Class II

Class IID-1418-2016

Product

4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info

Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ;

Why it was recalled

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

Recalling firm

Firm

Pharmedium Services, LLC

Notification channel

E-Mail

Type

Voluntary: Firm initiated

Address

150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity

455 bags

Distribution pattern

Nationwide

Timeline

Recall initiated

2016-05-05

FDA classified

2016-07-16

Posted by FDA

2016-07-27

Terminated

2018-03-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1418-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.