B. Braun Medical Inc recalls Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag,…

Recall date

June 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1343-2019

FDA classification

Class II

Brand / firm

B. Braun Medical Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.