morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dos...
FDA Recall #D-0870-2017 — Class II — May 18, 2017
Product Description
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
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
80 bags
Distribution
Nationwide in the USA
Code Information
LOT # 20170508@57, Use By: 08/06/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated