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fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoe...

FDA Recall #D-1014-2017 — Class II — July 14, 2017

Recall #D-1014-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40

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: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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