FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.
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 recall with voluntary firm-initiated withdrawal for manufacturing process deviations. No reported illnesses or injuries; consistent with precautionary manufacturing-quality recalls.
Plain-English summary
Akorn, Inc. is recalling PAREMYD (hydroxyamphetamine hydrobromide/tropicamide ophthalmic solution) 1%/0.25%, a prescription eye medication supplied in 15 mL dropper bottles. The recall affects 51,601 bottles distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The firm voluntarily initiated the recall beginning October 13, 2022, and the FDA classified it as a Class II recall on January 13, 2023.
The affected lot numbers and expiration dates are: Lot 0B55A (expires 1/31/2023), Lots 0D16A and 0D23A (expire 3/31/2023), Lot 0E51A (expires 4/30/2023), and Lot 1C46A (expires 2/29/2024). Additional information about the recall is available from the FDA and Akorn, Inc.
The recalled product
- Product
- PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- 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 (9)
- Lot: 0B55A
- EXP 1/31/2023
- 0D16A
- 0D23A
- EXP 3/31/2023
- 0E51A
- EXP 4/30/2023
- 1C46A
- EXP 2/29/2024
Distribution
Distributed nationwide across the United States.
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