CLASS II ONGOING Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Paremyd (hydroxyamphetamine hydrobromide/ tropicamide recalled by Akorn
Akorn is recalling Paremyd (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% per, distributed nationwide in the US. The recall was initiated on 13 Oct 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0152-2023
- FDA event ID
- 90948
- Recalling firm
- Akorn, Gurnee, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Oct 2022
- FDA classified
- 13 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- ADHD Medication
Timeline
| 13 Oct 2022 | Recall initiated by company | |
| 13 Jan 2023 | Classified by FDA | +92 days |
| 25 Jan 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations:
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Paremyd (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% per recalled?
Yes. Akorn recalled Paremyd (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25% per on 13 Oct 2022. The recall is Class II and its status is Ongoing. Recall number D-0152-2023.
Why was it recalled?
CGMP Deviations:
Which lots are affected?
Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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