Sermorelin and GHRP-2 Lyophilized Vials Recalled Due to Sterility Concerns
KRS Global Biotechnology is recalling 120 vials of Sermorelin and GHRP-2 because the company cannot assure the products are sterile.
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 lack of assurance of sterility without reported injuries, fitting the criteria for moderate risk.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 120 vials of Sermorelin (3 mg) and GHRP-2 (3 mg) lyophilized powder for subcutaneous use. The recall affects all lots that remain within their expiration dates.
The recall was initiated because the manufacturer cannot provide assurance of the sterility of the product. This means there is a risk that the medication may be contaminated.
The affected product was distributed nationwide. Consumers or healthcare providers with the affected medication should contact the manufacturer for further instructions.
The recalled product
- Product
- Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable Medication
- Affected units
- 120
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 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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