FDA Drug recall D-1412-2016

20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical… 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-1412-2016
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

20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48

Reason

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

Identifiers

code_info	Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp.… Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 1608

code_info

Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp.…

Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 ; Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 ; Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 ; Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 ; Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 ; Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 ; Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 ; Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 ; Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 ; Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 ; Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 ; Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 ; Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 ; Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 ; Service Code 2K8158 , Lot Number 1608

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-1412-2016%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.