Prescription eye drop recall due to manufacturing compliance issues
Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.
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 Class II FDA recall initiated voluntarily with no reported illnesses or injuries. The hazard involves manufacturing compliance deviations rather than a specific identified contamination or defect, which according to the severity rubric indicates low-risk or voluntary precautionary recalls.
Plain-English summary
Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution USP 0.1% (an eye drop medication) in 5 mL bottles sold under NDC 60429-957-05. The product is marketed by GSMS, Incorporated and was distributed nationwide throughout the United States.
The recall was initiated because the manufacturing process did not comply with Current Good Manufacturing Practice (CGMP) requirements. This is classified as a Class II recall by the FDA. Akorn initiated this voluntary recall in October 2022, which was classified by the FDA center on January 13, 2023.
The affected products are identified by specific lot numbers: 1C61A with expiration date February 28, 2023; and lots 1D86A and 1D07A with expiration date March 31, 2023. A total of 121,176 bottles are affected.
If you have this medication, contact your pharmacist or healthcare provider to verify whether your bottle is affected based on the lot number and expiration date.
The recalled product
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- cgmp-deviation
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 (5)
- Lot: 1C61A
- EXP 2/28/2023
- 1D86A
- 1D07A
- EXP 3/31/2023
Distribution
Distributed nationwide across the United States.
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