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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, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose…

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
Jun 1, 2016
Recall ID
D-0861-2016
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Injection starting Jan 21, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0861-2016 on Jun 1, 2016. Reason: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

Product description

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Lot numbers, UPCs & expiration codes

Lot #: P337857, Exp 07/31/16

Where it was sold

Nationwide and Puerto Rico

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-0861-2016
Classification
Class II
Status
Terminated
Recall initiated
Jan 21, 2016
FDA report date
Jun 1, 2016
Quantity
282,080 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-0861-2016, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
73118
Address
1 Baxter Pkwy
Code information
Lot #: P337857, Exp 07/31/16
Postal code
60015-4625
Report date
Jun 1, 2016
Product type
Drugs
Recall number
D-0861-2016
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
282,080 bags
Termination date
Feb 26, 2018
Reason for recall
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Jan 21, 2016
Initial firm notification
Letter
Center classification date
May 23, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0861-2016, published Jun 1, 2016. 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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