KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors
KRS Global Biotechnology is recalling 297 droptainers of a multi-ingredient ophthalmic solution 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 297 droptainers of Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution. The product is a prescription-only, 3 mL multi-dose solution distributed nationwide in the USA, Bermuda, and New Zealand.
The recall was initiated 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 09192017@20 with a BUD of 12/18/2017.
Consumers and healthcare providers should discontinue use of the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 297
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: 09192017@20 BUD: 12/18/2017
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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