The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0865-2017·Announced 2017-05-31

Cell Distributors Recalls Refresh Tears Eye Drops for Labeling Defects

Cell Distributors is recalling Refresh Tears eye drops because the product labels lack an NDC number, net weight, and Drug Facts Panel.

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, but the source text identifies the issue as a labeling error (missing NDC, net weight, and Drug Facts Panel) without reporting any illnesses or injuries, fitting the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Cell Distributors is voluntarily recalling Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5% Lubricant Eye Drops. The recall involves 2,634 bottles, including 58 5 mL bottles and 2,576 15 mL bottles, with expiration dates of August 2019. The products were distributed nationwide.

The recall was initiated due to labeling deficiencies. Specifically, the product labeling lacks a National Drug Code (NDC) number, net weight information, and does not contain the required Drug Facts Panel. This is classified as an FDA Class II recall.

Consumers who have these products should stop using them and contact Cell Distributors for further instructions or a refund. The recall is limited to the specific packaging and lot information described above.

The recalled product

Product
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
Manufacturer
Cell Distributors
Category
Drug — Ophthalmic
Hazard

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)

  • all lots Expiration date August 2019

Distribution

Distributed nationwide across the United States.

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