PlainRecalls
FDA Drug Moderate Class II Terminated

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22

Reported: November 8, 2017 Initiated: October 19, 2017 #D-0061-2018

Product Description

HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22

Reason for Recall

Lack Of Assurance Of Sterility.

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
60 bags
Distribution
Nationwide in the United States
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone Total Dose 1000 mcg) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0331-22. Recalled by SCA Pharmaceuticals, LLC. Units affected: 60 bags.
Why was this product recalled?
Lack Of Assurance Of Sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0061-2018.