FDA Drug recall D-1005-2017
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceu…
- FDA Drug
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceu… by Sca Pharmaceuticals, citing lack of Assurance of Sterility; product has the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1005-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-14 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
Reason
Lack of Assurance of Sterility; product has the potential to leak.
Identifiers
| code_info | Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017 |
|---|
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-1005-2017%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.