June 2019 FDA Recall Heparin Sodium In Dextrose by B. Braun Medical Inc
D-1343-2019 - Subpotent Drug

This Class II drug recall was voluntarily initiated by B. Braun Medical Inc on June 13, 2019 for the product Heparin Sodium In Dextrose. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1343-2019

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.
Initiated
06-13-2019
Reported
06-19-2019
Quantity
40,176 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83089
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
B. Braun Medical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-15-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : J7B259, Exp 31 Aug 2019

Affected Packages Involved in this Recall

0264-9567-10 Heparin Sodium In Dextrose
0264-9577-10 Heparin Sodium In Dextrose
0264-9587-20 Heparin Sodium In Dextrose