The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0201-2018·Announced 2018-01-17

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.

See all 47 products in this recall →

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