HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (To...
FDA Recall #D-0060-2018 — Class II — October 19, 2017
Product Description
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
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
128 syringes
Distribution
Nationwide in the United States
Code Information
Lot: 20170808@52 BUD: 11/06/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated