Drug Enforcement D-0434-2023

Subpotent Drug: low Anti-Factor IIa potency.

Status

Terminated

Classification

Class II

Report Date

March 15, 2023

Termination Date

March 13, 2024

Product Information

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.
Product quantity
30672
Reason for recall
Subpotent Drug: low Anti-Factor IIa potency.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
B. Braun Medical Inc
Address
2525 Mcgaw Ave

United States
Voluntary / Mandated
—
Status date
—

Codes & Dates

Recall number
D-0434-2023
Event ID
91769
Recall initiation date
March 1, 2023
Center classification date
March 6, 2023
Code info
Lot J2C017; Expiration: 9/30/2023.
More code info
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