FDA Drug recall D-1379-2016
10 mcg/mL Fentanyl Citrate and 0.075% 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 10 mcg/mL Fentanyl Citrate and 0.075% 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-1379-2016 |
| 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 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , E…Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , Exp. Date 6/2/2016 ; Lot Number 160740027C , Exp. Date 6/9/2016 ; Lot Number 160810024C , Exp. Date 6/16/2016 ; Lot Number 160880005C , Exp. Date 6/23/2016 ; Lot Number 160950036M , Exp. Date 6/29/2016 ; |
|---|
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-1379-2016%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.