Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility
| Brand name | HEPARIN SODIUM |
| Generic name | HEPARIN SODIUM |
| Active ingredient(s) | HEPARIN SODIUM |
| Distributed by / for | Hepalink USA Inc., Langhome, PA 19047-1885. Carton |
| NDC | 81952-111-06 |
| Full product label | Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01 |
| Recalling firm | Shenzhen Techdow Pharmaceutical Co., Ltd. |
| Distribution | Nationwide in the USA. |
| Quantity | 251,000 1 mL multidose vials |
| Recall initiated | 2026-10-01 |
| Report date | 2026-10-28 |
| Recall completed | — |
| Recall number | D-0050-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Shenzhen China |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗