KRS Global Biotechnology Recalls Chloramphenicol Otic Powder Due to Labeling Errors
KRS Global Biotechnology is recalling 100 jars of Chloramphenicol Otic Powder 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 (incorrect BUD) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 100 jars of Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder. The product is a prescription-only medication packaged in jars. The recall is 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 07282017@24 with a BUD of 1/24/2018, and 08162017@33 with a BUD of 2/12/2018. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Chloramphenicol 500 mg Sulfamethoxazole 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
- 100
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: 07282017@24 BUD: 1/24/2018
- 08162017@33 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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