PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 2, 2017 Initiated: July 14, 2017 #D-1007-2017

Product Description

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.

Details

Recalling Firm
SCA Pharmaceuticals
Units Affected
N/A
Distribution
Nationwide
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
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. Recalled by SCA Pharmaceuticals. Units affected: N/A.
Why was this product recalled?
Lack of Assurance of Sterility; product has the potential to leak.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 2, 2017. Severity: Moderate. Recall number: D-1007-2017.