KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors
KRS Global Biotechnology is recalling 2,239 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 moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 2,239 vials of Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only. The product is identified by Lot 08302017@11 and has a Beyond Use Date (BUD) of 2/26/2018.
The recall was initiated due to a labeling issue where the Beyond Use Date exceeds the expiration date of at least one ingredient used to make the final product. This discrepancy indicates that the product may have been used past the stability period of its components.
The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Biologic
- Hazard
- Affected units
- 2,239
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)
- Lot: 08302017@11 BUD: 2/26/2018
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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