Recalls / Class II
Class IID-0391-2020
Product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Affected lot / code info
- Lot #: RJM 10/19 RIA 09/19 SAN 01/20 SFF 06/20
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
- 48,168 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-0391-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.