KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units due to a lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 6,620 vials of Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use. The product is identified by NDC 3321673974 and is distributed nationwide. The recall affects all lots remaining within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. This classification indicates a potential risk of contamination, although the source text does not specify the nature of the contamination or report any specific illnesses or injuries.
Consumers and healthcare providers should stop using the recalled product and contact KRS Global Biotechnology, Inc. for further instructions or a refund. The product is prescription-only and intended for subcutaneous or intramuscular use.
The recalled product
- Product
- Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biologic
- Hazard
- Affected units
- 6,620
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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