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Class II: temporary or reversible health riskTerminated

Baxter Healthcare 0.9% Sodium Chloride Injection Recall

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

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
Aug 19, 2015
Recall ID
D-1326-2015
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Injection starting Jul 2, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1326-2015 on Aug 19, 2015. Reason: Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors. Status: Terminated.

Why it was recalled

Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.

Product description

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.

Lot numbers, UPCs & expiration codes

Lot #: C964601, Exp 4/30/2016

Where it was sold

TX and TN

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-1326-2015
Classification
Class II
Status
Terminated
Recall initiated
Jul 2, 2015
FDA report date
Aug 19, 2015
Quantity
189,912 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-1326-2015, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
71627
Address
1 Baxter Pkwy
Code information
Lot #: C964601, Exp 4/30/2016
Postal code
60015-4625
Report date
Aug 19, 2015
Product type
Drugs
Recall number
D-1326-2015
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
189,912 containers
Termination date
May 26, 2016
Reason for recall
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Distribution pattern
TX and TN
Recall initiation date
Jul 2, 2015
Initial firm notification
Letter
Center classification date
Aug 12, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1326-2015, published Aug 19, 2015. 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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