FDA Drug recall D-1378-2016
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,… 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-1378-2016 |
| 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 Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Service Code 2H8143 , Lot Number 160830115M , Exp. Date 6/22/2016 ; Service Code 2H8143 , Lot Number 160910155M , Exp.…Service Code 2H8143 , Lot Number 160830115M , Exp. Date 6/22/2016 ; Service Code 2H8143 , Lot Number 160910155M , Exp. Date 6/30/2016 ; Service Code 2K8448 , Lot Number 160480205M , Exp. Date 5/12/2016 ; Service Code 2K8448 , Lot Number 160610064M , Exp. Date 5/24/2016 ; Service Code 2K8448 , Lot Number 160760042M , Exp. Date 6/9/2016 ; Service Code 2K8448 , Lot Number 160890047M , Exp. Date 6/22/2016 ; |
|---|
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-1378-2016%22
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