Allergan Recalls Refresh P.M. Eye Ointment Due to Particulate Matter
Allergan is recalling Refresh P.M. eye ointment because small black particles from the tube cap may have entered the product.
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard involves particulate matter from the packaging, which is a quality defect rather than a high-risk biological or chemical contamination.
Plain-English summary
Allergan Sales, LLC is recalling Refresh P.M. (Mineral Oil, Petrolatum) Lubricant Eye Ointment. The recall involves 1,154,359 tubes distributed nationwide, in Puerto Rico, and in Barbados. The product is an over-the-counter ophthalmic ointment used for lubrication.
The recall was initiated due to customer complaints regarding the presence of small black particles. These particles were identified as fragments of the ointment tube cap. The issue occurs when the cap is unscrewed from the aluminum tube, which can generate particles that potentially enter the product.
Consumers should stop using the affected product and contact Allergan for a refund or replacement. The recall covers specific lot numbers and expiration dates ranging from May 2017 to February 2018. Users should check their product packaging against the provided lot and expiration codes to determine if their product is affected.
The recalled product
- Product
- REFRESH P.M. (MINERAL OIL, PETROLATUM)
- Brand
- REFRESH P.M.
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 1,154,359
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 #: 85165
- 85228
- Exp 05/17
- 85244
- 85351
- 85374
- 85397
- Exp 06/17
- 85561
- 85676
- 85694
- Exp 07/17
- 85834
- 85977
- 85985
- 86073
- Exp 08/17
- 85599
- 86290
- 86325
UPCs (1)
- 300230667043
Distribution
Part of a larger recall action
This product is one of 4 recalled by Allergan Sales, LLC 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.
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