FDA Drug recall D-1366-2016

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow pro…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow pro… 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-1366-2016
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

0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50

Reason

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

Identifiers

code_info	Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Ex… Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 1609600

code_info

Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Ex…

Lot Number 160380121M , Exp. Date 5/7/2016 ; Lot Number 160420113M , Exp. Date 5/11/2016 ; Lot Number 160450116M , Exp. Date 5/15/2016 ; Lot Number 160470127M , Exp. Date 5/16/2016 ; Lot Number 160480136M , Exp. Date 5/18/2016 ; Lot Number 160490132M , Exp. Date 5/18/2016 ; Lot Number 160520114M , Exp. Date 5/21/2016 ; Lot Number 160530129M , Exp. Date 5/23/2016 ; Lot Number 160590138M , Exp. Date 5/29/2016 ; Lot Number 160600038C , Exp. Date 5/30/2016 ; Lot Number 160620018C , Exp. Date 6/1/2016 ; Lot Number 160700020C , Exp. Date 6/9/2016 ; Lot Number 160740044C , Exp. Date 6/13/2016 ; Lot Number 160750033C , Exp. Date 6/14/2016 ; Lot Number 160760051C , Exp. Date 6/15/2016 ; Lot Number 160770024C , Exp. Date 6/16/2016 ; Lot Number 160810053C , Exp. Date 6/20/2016 ; Lot Number 160820033C , Exp. Date 6/21/2016 ; Lot Number 160880014C , Exp. Date 6/27/2016 ; Lot Number 160940015C , Exp. Date 7/2/2016 ; Lot Number 160950034C , Exp. Date 7/4/2016 ; Lot Number 1609600

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-1366-2016%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.