morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD ...
FDA Recall #D-0064-2018 — Class II — October 19, 2017
Product Description
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
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
a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag
Distribution
Nationwide in the United States
Code Information
Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated