Reported Nov 25, 2020 · Terminated
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile…
Hikma Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002
Is this the product you have?
- 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.
- Lot codes and dates
a) Vial Lot #s: 078338 Exp. 7/2021Lot 088391Exp. 08/2021098340Exp. 09/2021108325 Exp. 10/2021010018 Exp. 1/2023b) Carton Lot #: 068322Exp. 06/2021
- Amount recalled
- 2,100,646 Vials
Where it was sold
- Nationwide
Why it was recalled
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
This product could cause temporary or reversible health problems — stop using it.
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