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Class II: temporary or reversible health riskTerminated

Baxter Healthcare DOPamine Hydrochloride and 5% Dextrose INJ Recall

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA

Baxter Healthcare Corp. · Deerfield, IL

Risk level
Class II
Reported by FDA
Oct 8, 2014
Recall ID
D-0004-2015
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled DOPamine Hydrochloride and 5% Dextrose INJ starting Sep 29, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0004-2015 on Oct 8, 2014. Reason: Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Product description

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

Lot numbers, UPCs & expiration codes

Lot# P303172; Exp. 12/14

Where it was sold

Nationwide and Canada

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-0004-2015
Classification
Class II
Status
Terminated
Recall initiated
Sep 29, 2014
FDA report date
Oct 8, 2014
Quantity
11,808 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corp.

Original FDA data

Every field from FDA enforcement report D-0004-2015, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
69303
Address
1 Baxter Pkwy
Code information
Lot# P303172; Exp. 12/14
Postal code
60015-4625
Report date
Oct 8, 2014
Product type
Drugs
Recall number
D-0004-2015
Classification
Class II
Recalling firm
Baxter Healthcare Corp.
Product quantity
11,808 bags
Termination date
Sep 30, 2016
Reason for recall
Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Voluntary / mandated
Voluntary: Firm initiated
Product description
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Distribution pattern
Nationwide and Canada
Recall initiation date
Sep 29, 2014
Initial firm notification
Letter
Center classification date
Oct 2, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0004-2015, published Oct 8, 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.

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