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Class II: temporary or reversible health riskTerminated

B. Braun Medical Heparin Sodium Recall

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injec…

B. Braun Medical Inc · Irvine, CA

Risk level
Class II
Reported by FDA
May 24, 2023
Recall ID
D-0579-2023
Check your lot numberHow we source this data

Summary

B. Braun Medical recalled Heparin Sodium starting May 9, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0579-2023 on May 24, 2023. Reason: Subpotent: Low anti-factor IIa Potency. Status: Terminated.

Why it was recalled

Subpotent: Low anti-factor IIa Potency.

Product description

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

Lot numbers, UPCs & expiration codes

Lot Number: J1P154N, Exp: 31 May, 2023,

Where it was sold

Nationwide in the USA

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-0579-2023
Classification
Class II
Status
Terminated
Recall initiated
May 9, 2023
FDA report date
May 24, 2023
Quantity
1,380
Recall type
Voluntary: Firm initiated
Recalling firm
B. Braun Medical Inc

Original FDA data

Every field from FDA enforcement report D-0579-2023, exactly as published.

Show all FDA fields
City
Irvine
State
CA
Status
Terminated
Country
United States
Event ID
92292
Address
2525 Mcgaw Ave
Code information
Lot Number: J1P154N, Exp: 31 May, 2023,
Postal code
92614-5841
Report date
May 24, 2023
Product type
Drugs
Recall number
D-0579-2023
Classification
Class II
Recalling firm
B. Braun Medical Inc
Product quantity
1,380
Termination date
Mar 14, 2024
Reason for recall
Subpotent: Low anti-factor IIa Potency.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Distribution pattern
Nationwide in the USA
Recall initiation date
May 9, 2023
Initial firm notification
Letter
Center classification date
May 16, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0579-2023, published May 24, 2023. 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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