Recalls / Class II

Class IID-1387-2016

Product

10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,

Affected lot / code info

Service Code 2K8482 , Lot Number 160400113M , Exp. Date 5/10/2016 ; Service Code 2K8482 , Lot Number 160460097M , Exp. Date 5/16/2016 ; Service Code 2K8482 , Lot Number 160470229M , Exp. Date 5/17/2016 ; Service Code 2K8482 , Lot Number 160530109M , Exp. Date 5/23/2016 ; Service Code 2K8482 , Lot Number 160630133M , Exp. Date 6/2/2016 ; Service Code 2K8482 , Lot Number 160670166M , Exp. Date 6/6/2016 ; Service Code 2K8482 , Lot Number 160680146M , Exp. Date 6/7/2016 ; Service Code 2K8482 , Lot Number 160750150M , Exp. Date 6/14/2016 ; Service Code 2K8482 , Lot Number 160810139M , Exp. Date 6/20/2016 ; Service Code 2K8482 , Lot Number 160910246M , Exp. Date 6/30/2016 ; Service Code 2K8482 , Lot Number 160960036C , Exp. Date 7/5/2016 ; Service Code 2K8482 , Lot Number 160970147M , Exp. Date 7/6/2016 ; Service Code 2K8482 , Lot Number 161080277M , Exp. Date 7/17/2016 ; Service Code 2K8908 , Lot Number 160940041C , Exp. Date 5/10/2016 ; Service Code 2K8908 , Lot Number 160950030C , Exp. Date 5/11/2016 ; Service Code 2T6482 , Lot Number 160560209M , Exp. Date 5/26/2016 ; Service Code 2T6482 , Lot Number 160590158M , Exp. Date 5/29/2016 ; Service Code 2T6482 , Lot Number 160750214M , Exp. Date 6/14/2016 ;

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

1,277 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-1387-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.