The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0152-2023·Announced 2023-01-25

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
51,601

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.

Part of a larger recall action

This product is one of 27 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 27 products in this recall →

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