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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 numberLot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Where it was soldDistributed Nationwide in the USA
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% 2ml 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, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionDistributed Nationwide in the USA
Quantity1,324,072 vials
Recall initiated2020-12-07
Report date2020-12-23
Recall completed2023-07-18
Recall numberD-0169-2021
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

Recent drug recallsCheck another medication

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.