FDA Drug recall D-1421-2016

5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cas…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cas… 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-1421-2016
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

5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48

Reason

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

Identifiers

code_info	Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp… Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;

code_info

Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp…

Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;

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-1421-2016%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.