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Class II: temporary or reversible health riskTerminated

Baxter Healthcare Heparin Sodium and 0 Recall

Heparin Sodium and 0

Baxter Healthcare Corp · Deerfield, IL

Risk level
Class II
Reported by FDA
Jun 17, 2015
Recall ID
D-1131-2015
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Heparin Sodium and 0 starting Jun 3, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1131-2015 on Jun 17, 2015. Reason: Subpotent Drug; out of specification results for heparin raw material. Status: Terminated.

Why it was recalled

Subpotent Drug; out of specification results for heparin raw material

Product description

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

Lot numbers, UPCs & expiration codes

Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016

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-1131-2015
Classification
Class II
Status
Terminated
Recall initiated
Jun 3, 2015
FDA report date
Jun 17, 2015
Quantity
145,350 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp

Original FDA data

Every field from FDA enforcement report D-1131-2015, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
71356
Address
1 Baxter Pkwy
Code information
Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016
Postal code
60015-4625
Report date
Jun 17, 2015
Product type
Drugs
Recall number
D-1131-2015
Classification
Class II
Recalling firm
Baxter Healthcare Corp
Product quantity
145,350 containers
Termination date
Mar 14, 2017
Reason for recall
Subpotent Drug; out of specification results for heparin raw material
Voluntary / mandated
Voluntary: Firm initiated
Product description
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
Distribution pattern
Nationwide
Recall initiation date
Jun 3, 2015
Initial firm notification
Letter
Center classification date
Jun 9, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1131-2015, published Jun 17, 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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