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.
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 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.
- Category
- Drug — Ophthalmic
- Hazard
- 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.
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