KRS Global Biotechnology Recalls 7-Keto DHEA Capsules Due to Labeling Error
KRS Global Biotechnology is recalling 7-Keto DHEA 25mg capsules because the Beyond Use Date exceeds the expiration date 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 a labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc is recalling 7-Keto DHEA 25mg Capsules, a prescription-only medication. The recall was initiated due to a labeling error where the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used in its manufacture.
The affected product is identified by Lot 06082017@36 with a Beyond Use Date of 12/5/2017. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 7-Keto DHEA 25mg Capsule, 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
- 90
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: 06082017@36 BUD: 12/5/2017
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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