Skip to content
Recall Observatory FDA recall evidence

Drug product

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.

D-1343-2019

June 13, 2019

Class II

Product summary

Firm
B. Braun Medical Inc
Event
Event 83089
Status
Terminated
Classification
Class II
Quantity
40,176 bags
Official record key
drug-enforcement:D-1343-2019

Official wording

Reason: 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.

Code information: Lot #: J7B259, Exp 31 Aug 2019

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent