FDA Drug recall D-1398-2016
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Serv…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Serv… 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-1398-2016 |
| 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
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Ex…Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/2016 ; Lot Number 160730238M , Exp. Date 6/12/2016 ; Lot Number 160840215M , Exp. Date 6/23/2016 ; Lot Number 160880193M , Exp. Date 6/27/2016 ; Lot Number 160890187M , Exp. Date 6/28/2016 ; |
|---|
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-1398-2016%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.