fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct...
FDA Recall #D-1034-2017 — Class II — July 14, 2017
Product Description
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
Lots: 20170509@17 BUD: 8/7/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated