FDA Drug recall D-1368-2016

0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride by Pharmedium Services, citing presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1368-2016
Classification	Class II
Status	terminated
Initiated	2016-05-05
Published	2016-07-27
Last updated	2026-09-13 11:51 UTC
Company	Pharmedium Services
Distribution	US

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

Reason

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

Identifiers

code_info	Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp.… 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 16081

code_info

Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp.…

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 16081

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1368-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.