KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.
What this means for you
Illness, injury, or structural failure has been reported. 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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use. The product is identified by NDC 03321673964. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide. The recall includes all lots remaining within their expiry dates. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Affected units
- 2,219
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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