Status
Ongoing
Drug Enforcement D-0152-2023
CGMP Deviations:
Classification
Class II
Report Date
January 25, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 51,601 bottles
- Reason for recall
- CGMP Deviations:
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Akorn, Inc.
- Address
-
5605 Centerpoint Ct Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0152-2023
- Event ID
- 90948
- Recall initiation date
- October 13, 2022
- Center classification date
- January 13, 2023
- Code info
- Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
- More code info
- —