The Recall Desk
ModerateFDA (Drugs)·D-0233-2021·Announced 2021-01-27

Allergan Recalls Refresh Relieva Preservative-Free Eye Drops for Missing Labeling

Allergan is recalling Refresh Relieva Preservative-Free eye drops because the packaging is missing the instructions for use insert.

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 due to a labeling error (missing instructions for use). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity category.

Plain-English summary

Allergan, PLC. is recalling Refresh Relieva Preservative-Free Lubricant Eye Drops (Carboxymethylcellulose Sodium and Glycerin). The recall involves 100,634 bottles of the 10 mL sterile product, which is distributed nationwide. The specific lots affected are T0392 (Expiration: Jul. 2022) and T0843 (Expiration: Aug. 2022).

The reason for the recall is a labeling defect: the product is missing the instructions for use insert. This is an FDA Class II recall, indicating a situation that could temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers who have purchased these specific lots should stop using the product and contact Allergan for a refund or replacement. The product is an over-the-counter lubricant eye drop intended for ophthalmic use.

The recalled product

Product
REFRESH RELIEVA PRESERVATIVE FREE (CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN)
Brand
REFRESH RELIEVA PRESERVATIVE FREE
Manufacturer
Allergan, PLC.
Affected units
100,634

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: T0392 Exp. Jul. 2022
  • T0843 Exp. Aug. 2022

UPCs (1)

  • 300236634100

Distribution

Distributed nationwide across the United States.