KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors
KRS Global Biotechnology is recalling 7,862 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 7,862 vials of Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use. The product is a prescription-only medication manufactured in Boca Raton, Florida.
The recall was initiated due to a labeling defect where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product. This issue affects specific lots with BUDs ranging from November 2017 to March 2018.
The affected product was distributed nationwide in the USA, as well as in Bermuda and New Zealand. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biologic / Hormone
- Hazard
- Affected units
- 7,862
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 (4)
- Lots: 06222017@10 BUD: 12/19/2017
- 09272017@14 BUD: 3/26/2018
- 05312017@5 BUD: 11/27/2017
- 07192017@8 BUD: 1/15/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 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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