FDA-Drug2020-12-23Class II

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

Hikma Pharmaceuticals USA Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
1,324,072 vials
Manufactured in
2 Esterbrook Ln, N/A, Cherry Hill, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0169-2021

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