Olopatadine HCl ophthalmic solution recalled for manufacturing deviations
Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.
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: FDA Class II voluntary recall initiated by the firm with no reported illnesses or injuries. Meets the criterion for voluntary precautionary recalls without actual harm reported.
Plain-English summary
Akorn, Inc. has initiated a voluntary recall of Olopatadine HCl Ophthalmic Solution, USP 0.2%, in 2.5 mL bottles (NDC 17478-305-12). The recall affects 173,928 bottles distributed nationwide in the United States. The firm initiated the recall on October 13, 2022.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified at the Akorn manufacturing facility in Lake Forest, Illinois. CGMP compliance ensures that pharmaceutical products meet required quality and safety standards.
The affected lot numbers and expiration dates are: Lot 0L48A (expires 10/31/2022), Lot 0L55A (expires 10/31/2022), Lot 1C75A (expires 2/28/2023), Lot 1E18A (expires 4/30/2023), and Lot 1E20A (expires 4/30/2023). This is a prescription-only ophthalmic medication.
As of the date of this report, no illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- manufacturing-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 (8)
- Lot: 0L48A
- EXP 10/31/2022
- 0L55A
- 1C75A
- EXP 2/28/2023
- 1E18A
- 1E20A
- EXP 4/30/2023
Distribution
Distributed nationwide across the United States.
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