Drug Safety Alerts

B. Braun Heparin in Dextrose Injection Consumer-Level Recall

12/18/2020

On December 18, 2020, B. Braun Medical Inc. (BBMI) issued an extended withdrawal of non-expired batches Heparin in Dextrose injection products. This withdrawal was issued due to changes in their manufacturing requirements that were initiated to ensure their Heparin in Dextrose products meet USP requirements for Anti-Factor IIa potency throughout the labeled product shelf-life. This December 18, 2020 notice is an extension the July 2020 withdrawal and is intended to remove the remaining products which were produced prior to BBMI’s production changes.

The list of batches identified in this notice are part of the second phase of the withdrawal and is provided here.

Low potency of Heparin may result in reduced anti-coagulation effects. The clinical impact of reduced Heparin potency may range from mild, requiring dose titration, to serious and life-threatening in rare circumstances.

BBMI has advised that to date it has not received reports of serious injury or death associated with low potency. The rate of reports of lack of effect/potency associated with Heparin in Dextrose is 3.1 events per million units distributed.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this withdrawal, please call the B. Braun Medical Affairs Department at 1‑800-854-6851. You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.