FDA-Drug2020-11-25Class II
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.
Hikma Pharmaceuticals USA Inc.
Hazard
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Sold states
Nationwide in the U.S.
Affected count
2,100,646 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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0101-2021Don't want to check this manually?
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