US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 7, 2020 (6 years ago)

Sodium Chloride Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.

What was recalled

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

Recalling firm
Hikma Pharmaceuticals USA Inc.
NDC code
0641-0497-17
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0169-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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Reason Lack of Assurance of Sterility

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