Heparin Sodium Injection Recalled for Lack of Sterility Assurance
Shenzhen Techdow Pharmaceutical is recalling Heparin Sodium Injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility in Heparin Sodium Injection. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Shenzhen Techdow Pharmaceutical Co., Ltd. is recalling Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton. The recall is being conducted because of a lack of assurance of sterility. The product is distributed by Hepalink USA Inc. in Langhome, PA.
The affected product is identified by Lot# CU03232A with an expiration date of 1/31/2028. The recall involves 251,000 1 mL multidose vials. The product was distributed nationwide in the USA.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HEPARIN SODIUM (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM
- Manufacturer
- Shenzhen Techdow Pharmaceutical Co., Ltd.
- Category
- Drug — Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# CU03232A
- Exp 1/31/2028
UPCs (15)
- 0381952113018
- 0381952115074
- 0381952116019
- 0381952112103
- 0381952116064
- 0381952112059
- 0381952114091
- 0381952113063
- 0381952113032
- 0381952114046
- 0381952112042
- 0381952112097
- 0381952113087
- 0381952112066
- 0381952111069
Distribution
Distributed nationwide across the United States.
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