Drug product
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
D-1628-2020
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 86361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,843 bottles
- Official record key
drug-enforcement:D-1628-2020
Official wording
Reason: CGMP Deviations
Code information: Lot 8A11A exp 12/20
Distribution pattern: Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations