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Class II: temporary or reversible health riskTerminated

Hikma Pharmaceuticals Sodium Chloride Injection Recall

Sodium Chloride Injection, USP, 0

Hikma Pharmaceuticals USA Inc. · Cherry Hill, NJ

Risk level
Class II
Reported by FDA
Dec 23, 2020
Recall ID
D-0169-2021
Check your lot numberHow we source this data

Summary

Hikma Pharmaceuticals recalled Sodium Chloride Injection starting Dec 7, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0169-2021 on Dec 23, 2020. Reason: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0169-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 7, 2020
FDA report date
Dec 23, 2020
Quantity
1,324,072 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hikma Pharmaceuticals USA Inc.

Original FDA data

Every field from FDA enforcement report D-0169-2021, exactly as published.

Show all FDA fields
City
Cherry Hill
State
NJ
Status
Terminated
Country
United States
Event ID
86948
Address
2 Esterbrook Ln
Code information
Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Postal code
08003-4002
Report date
Dec 23, 2020
Product type
Drugs
Recall number
D-0169-2021
Classification
Class II
Recalling firm
Hikma Pharmaceuticals USA Inc.
Product quantity
1,324,072 vials
Termination date
Jul 18, 2023
Reason for recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Dec 7, 2020
Initial firm notification
E-Mail
Center classification date
Dec 16, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0169-2021, published Dec 23, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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