KRS Global Biotechnology Recalls Sermorelin Vials Due to Labeling Errors
KRS Global Biotechnology is recalling 597 vials of Sermorelin and related peptides because the Beyond Use Date exceeds the expiration 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 minor labeling errors regarding expiration dates without reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 597 vials of Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg, Lyophilized, For SC Use. The product is a prescription-only medication distributed nationwide in the USA, Bermuda, and New Zealand.
The recall was initiated due to labeling errors where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product. The affected lots are 06162017@12 with a BUD of 12/13/2017, and 08042017@1 with a BUD of 1/31/2018.
Consumers and healthcare providers should stop using the affected vials and contact KRS Global Biotechnology for instructions on return or disposal.
The recalled product
- Product
- Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, 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 — Peptide Hormones
- Hazard
- Affected units
- 597
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: 06162017@12 BUD: 12/13/2017
- 08042017@1 BUD: 1/31/2018
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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