FDA recall D-1007-2017

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 for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-14

Report date

2017-08-02

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1007-2017