Why it was recalled
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Product description
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
Lot numbers, UPCs & expiration codes
Lot #: J7B259, Exp 31 Aug 2019
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-1343-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 13, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 40,176 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B. Braun Medical Inc
Original FDA data
Every field from FDA enforcement report D-1343-2019, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83089
- Address
- 2525 Mcgaw Ave
- Code information
- Lot #: J7B259, Exp 31 Aug 2019
- Postal code
- 92614-5841
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1343-2019
- Classification
- Class II
- Recalling firm
- B. Braun Medical Inc
- Product quantity
- 40,176 bags
- Termination date
- Jul 15, 2022
- Reason for recall
- Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 13, 2019
- Initial firm notification
- Center classification date
- Jun 13, 2019