FDA-Drug2019-06-19Class II
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.
B. Braun Medical Inc
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.
Sold states
Nationwide in the USA
Affected count
40,176 bags
Manufactured in
2525 Mcgaw Ave, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1343-2019Don't want to check this manually?
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