May 2023 FDA Recall Heparin Sodium In Dextrose by B. Braun Medical Inc
D-0579-2023 - Subpotent
This Class II drug recall was voluntarily initiated by B. Braun Medical Inc on May 9, 2023 for the product Heparin Sodium In Dextrose. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0579-2023
Subpotent: Low anti-factor IIa Potency.
05-09-2023
05-24-2023
1,380
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
03-14-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Batch or Lot Expiration Information
Lot# Lot Number: J1P154N, Exp: 31 May, 2023
