Antihistamine eye drops recalled due to manufacturing process deviations
Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.
What this means for you
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: This is a voluntary precautionary recall classified as FDA Class II with no reported illnesses or injuries, meeting the rubric criterion for Moderate severity.
Plain-English summary
Olopatadine HCl Ophthalmic Solution, USP 0.1%, is being recalled due to manufacturing process deviations. This 5 mL antihistamine eye drop solution is manufactured by Akorn, Inc. and marketed by GSMS, Incorporated. The recall affects 163,996 bottles distributed nationwide in the United States.
The affected product lots are: 1L16A, 1L17A (expiring 10/31/2023); 1M29A (expiring 11/30/2023); and 2A05A (expiring 12/31/2023).
Akorn, Inc. voluntarily initiated this recall due to deviations from Current Good Manufacturing Practice (CGMP) standards. The firm's notification was submitted by letter in October 2022.
Consumers should discontinue use and consult with their healthcare provider or pharmacist. For more information, contact the FDA or your healthcare provider.
The recalled product
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic / Eye drops
- Hazard
- manufacturing-defect
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: 1L16A
- 1L17A
- EXP 10/31/2023
- 1M29A
- EXP 11/30/2023
- 2A05A
- EXP 12/31/2023
Distribution
Distributed nationwide across the United States.
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