FDA Drug recall D-1429-2016
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, S…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, S… 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-1429-2016 |
| 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 HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Service Code 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp.…Service Code 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016 ; Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016 ; Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016 ; Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016 ; Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016 ; Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016 ; Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016 ; Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016 ; Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016 ; Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016 ; Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016 ; Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016 ; Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016 ; Service Code 2H8477 , Lot Number 16 |
|---|
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-1429-2016%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.