FDA Drug recall D-1411-2016
20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 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 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 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-1411-2016 |
| 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 0.1% 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 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Ex…Lot Number 160600315M , Exp. Date 5/7/2016 ; Lot Number 160670256M , Exp. Date 5/14/2016 ; Lot Number 160730057M , Exp. Date 5/20/2016 ; Lot Number 160740144M , Exp. Date 5/20/2016 ; Lot Number 160800152M , Exp. Date 5/27/2016 ; Lot Number 160900142M , Exp. Date 6/5/2016 ; Lot Number 160910123M , Exp. Date 6/6/2016 ; Lot Number 160940037M , Exp. Date 6/9/2016 ; Lot Number 161080048M , Exp. Date 6/24/2016 ; |
|---|
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-1411-2016%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.