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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,

Recalled June 19, 2019 · FDA recall D-1343-2019 · B. Braun Medical

Hazard
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. · FDA Class II
Units
40,176 bags
Sold at
Nationwide in the USA

Description

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.

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.
Manufacturer(s)
B. Braun Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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, | RecallWatchUSA