KRS Global Biotechnology Recalls Amphotericin Otic Powder Due to Labeling Error
KRS Global Biotechnology is recalling 80 vials of Amphotericin Otic Powder 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 a labeling error regarding expiration dates, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 80 vials of Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder. The product is packaged in jars and is available by prescription only. 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 lot is 07282017@25 with a Beyond Use Date of 1/24/2018. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic/Ear
- Hazard
- Affected units
- 80
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: 07282017@25 BUD: 1/24/2018
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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