Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations
Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.
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: FDA Class II recall for manufacturing deviations in a pharmaceutical product. No illnesses or injuries have been reported. The score reflects potential risk from quality concerns in pharmaceutical manufacturing balanced against the absence of documented harm, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl Ophthalmic Solution, USP 0.1% nationwide. The product is a prescription eye drop medication supplied in 5 mL dropper bottles.
The recall was initiated due to current good manufacturing practice (CGMP) deviations identified at the manufacturer's facility. This is a voluntary recall initiated by the firm.
The recalled lot is Lot 1B41A with an expiration date of January 31, 2023. The product was distributed nationwide in the United States.
Consumers with this product should consult with their healthcare provider or pharmacist regarding next steps. Do not use the product without medical guidance.
The recalled product
- Product
- Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- manufacturing-defect
- contamination-risk
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 (2)
- Lot: Lot 1B41A
- EXP 1/31/2023
Distribution
Distributed nationwide across the United States.
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