Drug Safety Alerts

Heparin in Dextrose Consumer-Level Withdrawal

7/01/2020

On July 1, 2020, B. Braun Medical Inc. (BBMI) issued a consumer-level withdrawal of certain Heparin in Dextrose injection products. BBMI has advised that this withdrawal was issued as part of ongoing changes that BBMI is performing to ensure their Heparin in Dextrose products meet USP requirements for Anti-Factor IIa potency throughout the labeled product shelf-life, in which BBMI is incorporating revisions to internal manufacturing requirements. BMI has further advised that out of an abundance of caution, it is withdrawing non-expired batches of those Heparin in Dextrose products which were produced prior to implementation of these changes.

According to BBMI, in an effort to avoid potential market shortages this action is being taken in two phases whereby older batches and batches which were released with starting potencies close to the lower specification limit identified in the USP are being withdrawn first. In the second phase, the remaining batches produced prior to the updated controls will be removed. The time differential between phase one and phase two in being facilitated to permit BBMI time to produce replacement product with the modified controls while minimizing any potential impact to patient care due to supply shortages. At this time BBMI is not anticipating any major potential for supply chain disruption to end consumers.

A complete list of the affected products and lot numbers is provided here:

The batches identified in this notice are part of the first phase of the market withdrawal. BBMI will provide a subsequent notice identifying the additional batches subject to the withdrawal in approximately six months.

Low potency of Heparin may result in reduced anti-coagulation effects. The clinical impact of reduced Heparin potency may range from mild requiring titration to effect, 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.