fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Sing...
FDA Recall #D-0873-2017 — Class II — May 18, 2017
Product Description
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
370 bags
Distribution
Nationwide in the USA
Code Information
LOT # 20170506@14, Use By: 08/04/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated