Recalls / Class II

Class IID-1368-2016

Product

0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Affected lot / code info: Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 ; Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 ; Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 ; Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 ; Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 ; Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 ; Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 ; Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 ; Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 ; Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 ; Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 ; Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 ; Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 ; Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 ; Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 ; Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 ; Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 ; Service Code 2K8120 , Lot Number 160940060M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 160410183M , Exp. Date 5/11/2016 ; Service Code 2K8243 , Lot Number 160420152M , Exp. Date 5/12/2016 ; Service Code 2K8243 , Lot Number 160460131M , Exp. Date 5/16/2016 ; Service Code 2K8243 , Lot Number 160490239M , Exp. Date 5/19/2016 ; Service Code 2K8243 , Lot Number 160520184M , Exp. Date 5/22/2016 ; Service Code 2K8243 , Lot Number 160550125M , Exp. Date 5/25/2016 ; Service Code 2K8243 , Lot Number 160590160M , Exp. Date 5/29/2016 ; Service Code 2K8243 , Lot Number 160600171M , Exp. Date 5/30/2016 ; Service Code 2K8243 , Lot Number 160610227M , Exp. Date 5/31/2016 ; Service Code 2K8243 , Lot Number 160620142M , Exp. Date 6/1/2016 ; Service Code 2K8243 , Lot Number 160630199M , Exp. Date 6/2/2016 ; Service Code 2K8243 , Lot Number 160660168M , Exp. Date 6/5/2016 ; Service Code 2K8243 , Lot Number 160670236M , Exp. Date 6/6/2016 ; Service Code 2K8243 , Lot Number 160700192M , Exp. Date 6/9/2016 ; Service Code 2K8243 , Lot Number 160740235M , Exp. Date 6/13/2016 ; Service Code 2K8243 , Lot Number 160760190M , Exp. Date 6/15/2016 ; Service Code 2K8243 , Lot Number 160810280M , Exp. Date 6/20/2016 ; Service Code 2K8243 , Lot Number 160820234M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160830120M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160870168M , Exp. Date 6/26/2016 ; Service Code 2K8243 , Lot Number 160900173M , Exp. Date 6/29/2016 ; Service Code 2K8243 , Lot Number 160910176M , Exp. Date 6/30/2016 ; Service Code 2K8243 , Lot Number 160940041M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 161080168M , Exp. Date 7/17/2016 ; Service Code 2K9120 , Lot Number 160380034C , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160380105M , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160420030C , Exp. Date 5/12/2016 ; Service Code 2K9120 , Lot Number 160470039C , Exp. Date 5/17/2016 ; Service Code 2K9120 , Lot Number 160540034C , Exp. Date 5/24/2016 ; Service Code 2K9120 , Lot Number 160550029C , Exp. Date 5/25/2016 ; Service Code 2K9120 , Lot Number 160590078M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160600067M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160670187M , Exp. Date 6/6/2016 ; Service Code 2K9120 , Lot Number 160730076M , Exp. Date 6/11/2016 ; Service Code 2K9120 , Lot Number 160750233M , Exp. Date 6/14/2016 ; Service Code 2K9120 , Lot Number 160770001M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160770049M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160810056M , Exp. Date 6/19/2016 ; Service Code 2K9120 , Lot Number 160870069M , Exp. Date 6/26/2016 ; Service Code 2K9120 , Lot Number 160910184M , Exp. Date 6/30/2016 ; Service Code 2K9120 , Lot Number 160940154M , Exp. Date 7/3/2016 ; Service Code 2K9120 , Lot Number 160960190M , Exp. Date 7/5/2016 ; Service Code 2K9120 , Lot Number 161080156M , Exp. Date 7/17/2016 ; Service Code 2N1120 , Lot Number 160960241M , Exp. Date 7/5/2016 ; Service Code 2N9619 , Lot Number 160950229M , Exp. Date 7/4/2016 ; Service Code 2R3317-5 , Lot Number 160420122M , Exp. Date 5/12/2016 ; Service Code 2R3317-5 , Lot Number 160550206M , Exp. Date 5/24/2016 ; Service Code 2R3317-5 , Lot Number 160590164M , Exp. Date 5/29/2016 ; Service Code 2R3317-5 , Lot Number 160660159M , Exp. Date 6/5/2016 ; Service Code 2R3317-5 , Lot Number 160690151M , Exp. Date 6/7/2016 ; Service Code 2R3317-5 , Lot Number 160740252M , Exp. Date 6/13/2016 ; Service Code 2R3317-5 , Lot Number 160750181M , Exp. Date 6/14/2016 ; Service Code 2R3317-5 , Lot Number 160810298M , Exp. Date 6/20/2016 ; Service Code 2R3317-5 , Lot Number 160830222M , Exp. Date 6/22/2016 ; Service Code 2R3317-5 , Lot Number 160940150M , Exp. Date 7/3/2016 ; Service Code 2R3317-5 , Lot Number 161080209M , Exp. Date 7/17/2016 ; Service Code 3317NO , Lot Number 160380157M , Exp. Date 5/8/2016 ; Service Code 3317NO , Lot Number 160420173M , Exp. Date 5/11/2016 ; Service Code 3317NO , Lot Number 160540140M , Exp. Date 5/24/2016 ; Service Code 3317NO , Lot Number 160600185M , Exp. Date 5/30/2016 ; Service Code 3317NO , Lot Number 160630204M , Exp. Date 6/2/2016 ; Service Code 3317NO , Lot Number 160660172M , Exp. Date 6/5/2016 ; Service Code 3317NO , Lot Number 160700219M , Exp. Date 6/9/2016 ; Service Code 3317NO , Lot Number 160770174M , Exp. Date 6/16/2016 ; Service Code 3317NO , Lot Number 160840205M , Exp. Date 6/23/2016 ; Service Code 3317NO , Lot Number 160910210M , Exp. Date 6/30/2016 ; Service Code 3317NO , Lot Number 161080215M , Exp. Date 7/17/2016 ;

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: 2,874 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-1368-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.