FDA Drug Recalls

Recalls / Class II

Class IID-0454-2020

Product

CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Affected lot / code info
Lot #: 19087 03/21 18122 5/20 17289 9/19

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
50,304 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-0454-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls