D-0386-2020 Class II
FDA drug recall D-0386-2020 was initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 159,864 units.
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2019
- Initiation Date
- July 2, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159,864 units
Product Description
CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799143, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 19087 3/21 17289 9/19 19087 03/21 18122 5/20