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fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 ...

FDA Recall #D-1000-2017 — Class II — July 14, 2017

Recall #D-1000-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.

Reason for Recall

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have 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

130 bags

Distribution

Nationwide in the USA

Code Information

Lot: 20170707@27, BUD: 10/5/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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