FDAFDA · Food and drugs·Recall number D-1628-2020
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Published October 7, 2020 · Recall initiated: September 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
- Lot
- Lot 8A11A exp 12/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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