FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach
AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.
What this means for you
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: Sterility assurance failure in an eye ointment is a potential risk-of-harm situation that warrants FDA Class II classification. Without reported adverse events, the maximum severity per the rubric is High.
Plain-English summary
Refresh P.M. is a lubricant eye ointment containing mineral oil and white petrolatum, distributed by AbbVie in 3.5-gram tubes. The manufacturer is recalling multiple lots due to potential breaches in tube seals that could compromise the sterility assurance of the product.
The affected lots were distributed nationwide throughout the United States as well as to Australia, Canada, and Great Britain. Specific lot numbers and expiration dates are identified in the FDA recall notice.
The recalled product
- Product
- Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-breach
- seal-breach
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: 387392
- 387393
- 387394
- Exp. Feb 25
- 387395
- 388729
- 388730
- 388731
- 388732
- 390391
- 390404
- Exp. Apr 25
- 391688
- 391734
- Exp. Oct 25
- 392616
- 392620
- Exp. Dec 25
- 392987
- 393560
Distribution
Distributed nationwide across the United States.
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