Recalls / Class II
Class IID-0374-2020
Product
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
- Affected lot / code info
- Lot #: 17196 08/19 17192 09/19 17355 11/19 18024 01/20 18036 02/20 18237 09/20 18293 12/20 18105 04/20 18179 07/20 19040 2/21
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Altaire Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 311 W Ln, PO Box 849, Aquebogue, New York 11931-0849
Distribution
- Quantity
- 365,832 units
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-07-02
- FDA classified
- 2019-11-15
- Posted by FDA
- 2019-11-27
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0374-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.