Recalls / Class II

Class IID-1382-2016

Product

10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27

Affected lot / code info

Lot Number 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ;

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

740 BD syringes

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-1382-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.