D-0399-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

FDA drug recall D-0399-2020 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: 2,042,136 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
2,042,136 units

Product Description

Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-874-13

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

19128 05/21 19009 01/21 19003 01/21 19034 01/21 19060 02/21 19061 02/21 18252 10/20 18058 03/20 18224 09/20 18185 07/20 18152 06/20 18159 06/20 18091 04/20 18090 04/20 18069 03/20