FDA Drug recall D-1414-2016
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 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 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 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-1414-2016 |
| 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
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), 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 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp.…Service Code 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 ; Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 ; Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 ; Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 ; Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 ; Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 ; Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 ; Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 ; Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 ; Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 ; Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 ; Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 ; Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 ; Service Code 2K8180 , Lot Number 1609 |
|---|
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-1414-2016%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.