Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. We...
FDA Recall #D-0169-2021 — Class II — December 7, 2020
Product Description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Recalling Firm
Hikma Pharmaceuticals USA Inc. — Cherry Hill, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,324,072 vials
Distribution
Distributed Nationwide in the USA
Code Information
Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated