KRS Global Biotechnology Recalls Chloramphenicol Otic Capsules Due to Labeling Errors
KRS Global Biotechnology is recalling Chloramphenicol 50 mg/Sulfamethoxazole 50 mg/Amphotericin-B 5 mg 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 for minor labeling errors or low-risk contamination.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling Chloramphenicol 50 mg/Sulfamethoxazole 50 mg/Amphotericin-B 5 mg capsules, intended for otic use only. The recall involves 90-capsule bottles from Lot 08212017@24, which has a Beyond Use Date (BUD) of 2/17/2018.
The recall was initiated due to a labeling error where the Beyond Use Date exceeds the expiration date of at least one ingredient used to make the final product. This discrepancy may affect the stability or safety of the medication.
The affected products were distributed nationwide in the USA, Bermuda, and New Zealand. Consumers and healthcare providers should stop using the recalled capsules and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use Only, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic/Ear 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: 08212017@24 BUD: 2/17/2018
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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