HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single D...
FDA Recall #D-0875-2017 — Class II — May 18, 2017
Product Description
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
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
87 bags
Distribution
Nationwide in the USA
Code Information
LOT # 20170505@23, 20170505@28, Use By: 08/03/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated