KRS Global Biotechnology Recalls Sermorelin Tablets Due to Labeling Errors
KRS Global Biotechnology is recalling Sermorelin 500 mcg tablets because the expiration date exceeds the shelf life of an ingredient.
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 criteria for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 3,000 tablets of Sermorelin 500 mcg Orally Disintegrating Tablets (ODT). The recall is due to a labeling error where the Beyond Use Date (BUD) exceeds the expiration date of at least one ingredient used to make the final product.
The affected product is Lot 07112017@32 with a BUD of 1/7/2018. The tablets were distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,000
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: 07112017@32 BUD: 1/7/2018
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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