FDA-Drug2026-10-16Class IIPROCESSING DEFECT
Hepalink Heparin Sodium Injection recalled for lack of sterility assurance
What this means
Hepalink USA is recalling Heparin Sodium Injection (5,000 USP Units/mL) due to lack of assurance that the product is sterile. The affected multidose vials have lot number CU03232A with an expiration date of January 31, 2028. This product is used in hospitals and medical settings.
- If you administer or dispense this product, stop using vials from lot CU03232A immediately.
- Contact your supplier or Hepalink USA for instructions on return or disposal.
- Verify the lot number and expiration date on your vials before use.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
251,000 1 mL multidose vials
Manufactured in
19 Gaoxinzhongyi Road, Nanshan District, Shenzhen, China
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0050-2027Want us to check the next one for you?
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