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fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in...

FDA Recall #D-0063-2018 — Class II — October 19, 2017

Recall #D-0063-2018 Date: October 19, 2017 Classification: Class II Status: Terminated

Product Description

fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64

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

20 bags inside rigid translucent plastic cases (CADD)

Distribution

Nationwide in the United States

Code Information

Lot: 20170815@26 BUD: 11/13/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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