RecallRadar

FDA Drug recall D-1007-2017

BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmace…

On 2017-08-02 the FDA classified a Class II recall of BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmace… by Sca Pharmaceuticals, citing lack of Assurance of Sterility; product has the potential to leak.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1007-2017
ClassificationClass II
Statusterminated
Initiated2017-07-14
Published2017-08-02
Last updated2026-09-13 11:51 UTC
CompanySca Pharmaceuticals
DistributionUS

Product

BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40

Reason

Lack of Assurance of Sterility; product has the potential to leak.

Identifiers

code_infoLot: 20170501@69 BUD: 7/30/2017

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-1007-2017%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.