FDA recall D-1343-2019

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.

Reason for recall

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-06-13

Report date

2019-06-19

Termination date

2022-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1343-2019