Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B
Summary
The FDA issued a Class II for Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextros by B. Braun Medical Inc. Reason: Subpotent Drug: low Anti-Factor IIa potency..
Details
Source
Drug Recall
External ID
D-0434-2023
Action Date
2023-03-15
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot J2C017; Expiration: 9/30/2023.
Quantity Affected: 30672
Reason for Recall
Subpotent Drug: low Anti-Factor IIa potency.
Distribution
Nationwide in the USA
Recall Initiated: 2023-03-01
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
B. Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B. Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B. Braun Medical Inc have FDA actions?
B. Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0434-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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