FDA recall D-1006-2017

Product

BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40

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-1006-2017