KRS Global Biotechnology Recalls Chloramphenicol and Amphotericin Otic Powder
KRS Global Biotechnology is recalling 20 jars of Chloramphenicol and 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific issue is a labeling error regarding the expiration date, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 20 jars of Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder. The product is packaged in jars and is available by prescription only. The specific lot number is 08162017@32, and the Beyond Use Date (BUD) is listed as 2/12/2018.
The recall was initiated due to a labeling issue where the Beyond Use Date exceeds the expiration date of at least one ingredient used to make the final product. This discrepancy indicates that the product may not be stable or effective for the entire duration stated on the label.
The affected product was distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Chloramphenicol 500 mg Amphotericin 50 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/OTC
- Hazard
- Affected units
- 20
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: 08162017@32 BUD: 2/12/2018
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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