FDAFDA · Food and drugs·Recall number D-1343-2019
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.
Published June 19, 2019 · Recall initiated: June 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- HEPARIN SODIUM IN DEXTROSE
- Manufacturer
- B. Braun Medical Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot #: J7B259, Exp 31 Aug 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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