PlainRecalls
FDA Drug Moderate Class II Terminated

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

Reported: March 15, 2023 Initiated: March 1, 2023 #D-0434-2023

Product Description

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.

Reason for Recall

Subpotent Drug: low Anti-Factor IIa potency.

Details

Recalling Firm
B. Braun Medical Inc
Units Affected
30672
Distribution
Nationwide in the USA
Location
Irvine, CA

Frequently Asked Questions

What product was recalled?
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.. Recalled by B. Braun Medical Inc. Units affected: 30672.
Why was this product recalled?
Subpotent Drug: low Anti-Factor IIa potency.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 15, 2023. Severity: Moderate. Recall number: D-0434-2023.