FDA Drug recall D-1395-2016
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 25…
- 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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 25… 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-1395-2016 |
| 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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, 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 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp.…Service Code 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 ; Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 ; Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 ; Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 ; Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 ; Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 ; Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 ; Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 ; Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 ; Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 ; Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 ; Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 ; Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 16066 |
|---|
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-1395-2016%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.