Akorn Artificial Tears Ointment Recalled for Non-Sterility
Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.
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: This is an FDA Class II recall for a sterile product with documented contamination (Bacillus cereus). Although no illnesses have been reported, Bacillus cereus is a pathogen capable of causing infection, particularly in eye tissue, and the product failed sterility specifications, creating a genuine risk of harm.
Plain-English summary
Akorn, Inc. is recalling 142,188 tubes of Artificial Tears Ointment, a sterile lubricant eye ointment. The product is packaged in 3.5 g (1/8 oz.) tubes and was manufactured in Lake Forest, Illinois (NDC 17478-062-35). The recall affects lots 9G01A (expiration 06/2022), 9H32A (expiration 07/2022), 9K82A, and 9K82B (expiration 09/2022).
The recall was initiated because sterility testing performed during 12-month controlled room temperature stability testing did not meet specifications. Microbiological investigation identified the contaminating organism as a member of the Bacillus cereus group.
The product has been distributed nationwide in the USA and Puerto Rico. Consumers who have purchased affected lots should stop using the product and consult their healthcare provider if they have any concerns.
The recalled product
- Product
- Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic / Eye Care
- Hazard
- non-sterility
- bacillus-cereus
- microbial-contamination
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 (7)
- Lot #: 9G01A
- Exp 06/2022
- 9H32A
- Exp 07/2022
- 9K82A
- 9K82B
- Exp 09/2022
Distribution
Distributed nationwide across the United States.
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