Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink U
Summary
The FDA issued a Class II for Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vial by Shenzhen Techdow Pharmaceutical Co., Ltd.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0050-2027
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot# CU03232A, Exp 1/31/2028
Quantity Affected: 251,000 1 mL multidose vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-01
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shenzhen Techdow Pharmaceutical Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shenzhen Techdow Pharmaceutical Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Shenzhen Techdow Pharmaceutical Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0050-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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