Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, F...
FDA Recall #D-0101-2021 — Class II — November 3, 2020
Product Description
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL 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
2,100,646 Vials
Distribution
Nationwide in the U.S.
Code Information
a) Vial Lot #s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/2023; b) Carton Lot #: 068322, Exp. 06/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated