CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Heparin Sodium 25,000 USP units recalled by B. Braun Medical
B. Braun Medical is recalling Heparin Sodium 25,000 USP units per (100 USP units per mL) in 5% Dextrose Injection Excel, distributed nationwide in the US. The recall was initiated on 13 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1343-2019
- FDA event ID
- 83089
- Recalling firm
- B. Braun Medical, Irvine, CA
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2019
- FDA classified
- 13 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Thinners
Timeline
| 13 Jun 2019 | Recall initiated by company | |
| 13 Jun 2019 | Classified by FDA | +0 days |
| 19 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Heparin Sodium 25,000 USP units per (100 USP units per mL) in 5% Dextrose Injection Excel recalled?
Yes. B. Braun Medical recalled Heparin Sodium 25,000 USP units per (100 USP units per mL) in 5% Dextrose Injection Excel on 13 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1343-2019.
Why was it recalled?
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.
Which lots are affected?
Lot #: J7B259, Exp 31 Aug 2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heparin Sodium recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |