morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total ...
FDA Recall #D-0999-2017 — Class II — July 14, 2017
Product Description
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
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
220 bags
Distribution
Nationwide in the USA
Code Information
Lots: a) 20170707@34, BUD:10/5/2017; 20170710@21, BUD: 10/8/2017; b) 20170706@44, BUD: 10/4/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated