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Class II · ModerateRecall completed

Sodium Chloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) 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.
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHikma Pharmaceuticals USA Inc.
Brand nameSODIUM CHLORIDE
Generic nameSODIUM CHLORIDE
Active ingredient(s)SODIUM CHLORIDE
Distributed by / forHikma Pharmaceuticals USA Inc.
NDC0641-0497-17
Show the full FDA record
Full product labelSodium 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.
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide in the U.S.
Quantity2,100,646 Vials
Recall initiated2020-11-03
Report date2020-11-25
Recall completed2022-11-17
Recall numberD-0101-2021
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.