D-0382-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

FDA drug recall D-0382-2020 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: 45864 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
45864 units

Product Description

CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 495334,Product Size: 0.6 mL x 60 count, 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 #: RGF, Exp 07/19; RHN, Exp 08/19; RIH, Exp 09/19; RJP, Exp 10/19; RKN, Exp 11/19; SDC Exp 04/20; SFC, Exp 06/20; SFJ, Exp 06/20; SGI, Exp 07/20