Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Reported: October 7, 2020 Initiated: September 3, 2020 #D-1628-2020
Product Description
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 25,843 bottles
- Distribution
- Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01. Recalled by Akorn, Inc.. Units affected: 25,843 bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 7, 2020. Severity: Moderate. Recall number: D-1628-2020.
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