FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Baxter Healthcare 0.9% Sodium Chloride Injection Recall

0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthca…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
Sep 17, 2014
Recall ID
D-1583-2014
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Injection starting Jul 30, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1583-2014 on Sep 17, 2014. Reason: Lack of Assurance of Sterility; complaints of mold in the overpouch. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility; complaints of mold in the overpouch

Product description

0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03

Lot numbers, UPCs & expiration codes

Lot #C926642, Product Code: 2B1323N

Where it was sold

Nationwide

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-1583-2014
Classification
Class II
Status
Terminated
Recall initiated
Jul 30, 2014
FDA report date
Sep 17, 2014
Quantity
157,080 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1583-2014, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
69144
Address
1 Baxter Pkwy
Code information
Lot #C926642, Product Code: 2B1323N
Postal code
60015-4625
Report date
Sep 17, 2014
Product type
Drugs
Recall number
D-1583-2014
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
157,080 containers
Termination date
Jun 8, 2016
Reason for recall
Lack of Assurance of Sterility; complaints of mold in the overpouch
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Distribution pattern
Nationwide
Recall initiation date
Jul 30, 2014
Initial firm notification
Letter
Center classification date
Sep 5, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1583-2014, published Sep 17, 2014. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls