Shenzhen Techdow Pharmaceutical Co., Ltd.: Heparin Sodium Injection, Usp, 5,000 Usp Units/ml
Recall Summary Heparin Sodium Injection (a blood thinner) in 1mL vials containing 5,000 units is being recalled nationwide because the manufacturer cannot confirm the product is sterile. The recalled product was distributed by Hepalink USA Inc. and has specific lot/carton numbers listed (NDC 81952-111-06 for cartons and NDC 81942-111-01 for individual vials).
- Recalling firm
- Shenzhen Techdow Pharmaceutical Co., Ltd.
- Product
- 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
- Reason
- Lack of Assurance of Sterility
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/fb5491f2-9bf3-48bd-b749-ae1c96521cd7