Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations
Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.
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: FDA Class II with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and precautionary, initiated by the manufacturer for manufacturing process (CGMP) deviations without specific disclosed hazard.
Plain-English summary
Akorn, Inc. is voluntarily recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution, USP, 0.5%, distributed nationwide. The recalled product is a prescription eye medication supplied in 3 mL dropper bottles. The affected lot is 1E28A with an expiration date of April 30, 2023. The recall number is D-0144-2023.
The recall was initiated due to manufacturing deviations that did not comply with Current Good Manufacturing Practice (CGMP) requirements. No illnesses or injuries have been reported in connection with this recall.
Patients using this medication should not stop taking it without consulting their healthcare provider. Patients with affected lot numbers should contact their pharmacist or healthcare provider for replacement product or further guidance. The pharmacy or healthcare provider can verify the lot number on the prescription bottle.
The recalled product
- Product
- Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- cgmp-deviation
- 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 (3)
- Lot
- Expiry: Lots 1E28A
- exp 4/30/2023
Distribution
Distributed nationwide across the United States.
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