FDA Drug recall D-1367-2016
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119… 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-1367-2016 |
| 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
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), 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 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp.…Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 ; Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 ; Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 ; Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 ; Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 ; Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 ; Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 ; Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 ; Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 ; Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 ; Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 ; Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 ; Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 ; Service Code 2K8217 , Lot Number 160 |
|---|
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-1367-2016%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.