Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a potential sterility breach in an ophthalmic product with no reported illnesses or injuries. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High (3) classification.
Plain-English summary
Allergen, an AbbVie company, is recalling specific lots of Refresh LACRI-LUBE lubricant eye ointment in 0.12 oz (3.5g) tubes due to a potential lack of assurance of sterility. The impacted lots may contain a breach in the tube seal.
The recall affects approximately 763,426 tubes distributed nationwide in the USA and in Australia, Canada, and Great Britain. Affected lot numbers and expiration dates are publicly available from the manufacturer.
Consumers who possess Refresh LACRI-LUBE should verify their product's lot number and expiration date against the manufacturer's recall list. If their product is among the recalled lots, the product should not be used.
The recalled product
- Product
- Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Ophthalmic / Eye Care
- Affected units
- 763,426
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 (20)
- Lot: 387489
- Exp. Oct 24
- 387490
- Exp. Jun 25
- 390422
- Exp. Nov 24
- 390424
- 391692
- 391893
- Exp. Nov 25
- 394822
- Exp. Feb 26
- 395991
- Exp. Mar 26
- 397905
- 397973
- 397974
- Exp May 26
- 399019
- 399254
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AbbVie 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 2 products in this recall →Related recalls
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