Heparin Sodium 25 — Class II drug recall D-1343-2019
Terminated recall by B. Braun Medical Inc, reported 2019-06-19, distributed nationwide. Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is
| Recall number | D-1343-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical Inc, Irvine, CA, United States |
| Recall initiated | 2019-06-13 |
| Classified | 2019-06-13 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2022-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 40,176 bags |
| Reason classes | potency |
| NDC | 00264-9567, 00264-9567-10, 00264-9577, 00264-9577-10, 00264-9587, 00264-9587-20 |
| Lot numbers | J7B259 |
| Expiration dates | 2019-08-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1343-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.