KRS Global Biotechnology Recalls Sermorelin Acetate Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 157 vials of Sermorelin Acetate/GHRP6 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 dates, which aligns with the rubric for moderate severity.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 157 vials of Sermorelin Acetate 3 mg/GHRP6 3 mg, Lyophilized Vial, Rx Only. The recall is due to labeling issues where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product, or where lot and expiration dates are incorrect or missing.
The affected product is identified by Lot 06272017@4 with a BUD of 12/24/2017. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact KRS Global Biotechnology for further instructions.
The recalled product
- Product
- Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 157
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: 06272017@4 BUD: 12/24/2017
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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