HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL (HYDROmorphone...
FDA Recall #D-0061-2018 — Class II — October 19, 2017
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.
Recalling Firm
SCA Pharmaceuticals, LLC — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
60 bags
Distribution
Nationwide in the United States
Code Information
Lot: 20170816@65 BUD: 10/30/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated