FDA Drug recall D-1386-2016

10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Ca…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Ca… 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-1386-2016
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

10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,

Reason

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

Identifiers

code_info	Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp.… Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160

code_info

Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp.…

Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160

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-1386-2016%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.