Heparin Sodium In Dextrose Injection
FDA Recall NDC 0264-9577
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Heparin Sodium In Dextrose (NDC 0264-9577). A significant event, classified as Class II, was initiated on May 09, 2023 by B. Braun Medical Inc.. The reported reason for this action was: "Subpotent: Low anti-factor IIa Potency."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Subpotent: Low anti-factor IIa Potency.
May 09, 2023
May 24, 2023
1,380
Recall Profile & Regulatory Data
Event ID
92292
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 14, 2024
Product Description
Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,
Batch or Lot Expiration Information
Lot# Lot Number: J1P154N, Exp: 31 May, 2023
Affected Packages Involved in this Recall
0264-9567-10Product
0264-9577-10Product
0264-9587-20Product
Class II Terminated
Subpotent Drug: low Anti-Factor IIa potency.
Mar 01, 2023
Mar 15, 2023
30672
Recall Profile & Regulatory Data
Event ID
91769
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Distribution Pattern
Nationwide in the USA
Termination Date
Mar 13, 2024
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.
Batch or Lot Expiration Information
Lot# Lot J2C017; Expiration: 9/30/2023.
Affected Packages Involved in this Recall
0264-9567-10Product
0264-9577-10Product
0264-9587-20Product
Class II Terminated
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.
Jun 13, 2019
Jun 19, 2019
40,176 bags
Recall Profile & Regulatory Data
Event ID
83089
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 15, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# : J7B259, Exp 31 Aug 2019
Affected Packages Involved in this Recall
0264-9567-10Product
0264-9577-10Product
0264-9587-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
