Drug 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
D-0152-2023
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 90948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51,601 bottles
- Official record key
drug-enforcement:D-0152-2023
Official wording
Reason: CGMP Deviations:
Code information: Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations