KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors
KRS Global Biotechnology is recalling 2,274 vials of Human Chorionic Gonadotropin 20,000 iu 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 minor labeling errors regarding expiration dates, which fits the rubric for moderate severity.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 2,274 vials of Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
The recall was initiated because of labeling errors where the Beyond Use Date (BUD) exceeded the expiration date of at least one ingredient used to make the final product. Specific lots affected include 06082017, 06152017, 07272017, 10042017, and 09282017.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Human Chorionic Gonadotropin 20,000 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
- Hazard
- Affected units
- 2,274
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 (5)
- Lots: 06082017@33 BUD: 12/5/2017
- 06152017@4 BUD: 12/12/2017
- 07272017@4 BUD: 1/23/2018
- 10042017@22 BUD: 4/2/2018
- 09282017@3 BUD: 3/27/2018
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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