KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors
KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.
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 2/5 (Moderate).
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 criteria for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 1,203 vials of Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only. The recall was initiated because the products have incorrect or missing lot and/or expiration dates. Specifically, the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected lots are 06212017@19 with a BUD of 12/18/2017, and 10052017@1 with a BUD of 4/3/2018. These products were distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the affected vials and contact KRS Global Biotechnology for further instructions or a return.
The recalled product
- Product
- Human Chorionic Gonadotropin 2,500 Units, 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
- Hazard
- Affected units
- 1,203
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)
- Lots: 06212017@19 BUD: 12/18/2017
- 10052017@1 BUD: 4/3/2018
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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