Why it was recalled
Subpotent Drug: low Anti-Factor IIa potency.
Product description
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
Lot numbers, UPCs & expiration codes
Lot J2C017; Expiration: 9/30/2023.
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-0434-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 1, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 30672
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-0434-2023, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 91769
- Address
- 2525 Mcgaw Ave
- Code information
- Lot J2C017; Expiration: 9/30/2023.
- Postal code
- 92614-5841
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0434-2023
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 30672
- Termination date
- Mar 13, 2024
- Reason for recall
- Subpotent Drug: low Anti-Factor IIa potency.
- Product description
- Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 6, 2023