Summary

Company Announcement Date:
July 03, 2019
FDA Publish Date:
July 05, 2019
Product Type:
Drugs
Over-the-Counter Drugs
Reason for Announcement:

Recall Reason Description

Potential for nonsterility

Company Name:
Altaire Pharmaceuticals, Inc.
Brand Name:

Brand Name(s)

Equate and Support Harmony

Product Description:

Product Description

Over-the-Counter (OTC) drug products


Company Announcement

Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below. As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.

Product Description: Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17196 07/19 08/15/2017
17292 09/19 11/03/2017
17355 11/19 12/22/2017
19040 02/21 03/26/2019

Product Description: Equate Eye Allergy Relief Drops W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19128 05/21 06/20/2019
19009 01/21 01/28/2019
19003 01/21 02/21/2019
19034 01/21 03/07/2019
19060 02/21 04/22/2019
19061 02/21 05/21/2019
18252 10/20 11/21/2018
18058 03/20 03/22/2018
18224 09/20 09/26/2018
18185 07/20 08/27/2018
18152 06/20 07/05/2018
18159 06/20 07/18/2018
18091 04/20 06/07/2018
18090 04/20 04/27/2018
18069 03/20 04/04/2018

Product Description: Equate Sterile Lubricant Stye Ointment W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SAJ 01/21 03/23/2018
SFE 06/21 07/05/2018
SIA 09/21 10/23/2018
RIE 09/20 09/28/2017
REH 05/20 07/21/2017
RAD 01/20 05/23/2017
TAH 01/22 02/14/2019
TDD 04/22 05/29/2019

Product Description: Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
17384 12/19 01/17/2018
17259 08/19 10/27/2017
19002 01/21 01/22/2019
19041 02/21 04/09/2019
18222 09/20 09/25/2018
18084 04/20 06/15/2018

Product Description: Equate Restore PM Nighttime Lubricant Eye Ointment W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
SKG 08/21 12/18/2018
SHK 08/21 10/09/2018
SHJ 08/21 09/13/2018
SEC 05/21 07/13/2018
SCB 03/21 01/14/2019
SBC 02/21 03/21/2019
RLB 12/20 12/27/2017
RBB 02/20 04/28/2017
RHR 08/20 10/04/2017
RFK 06/20 07/28/2017
RAB 01/20 03/21/2017
TAD 01/22 01/25/2019
TAQ 01/22 03/18/2019
TBI 02/22 04/29/2019
TDB 04/22 06/07/2019
QHE 08/19 09/27/2016
QJD 10/19 12/07/2016
SGE 07/21 08/07/2018

Product Description: Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL

Lot Number Expiration Date Manufacturer Initial Ship Date
KT19146 02/21 06/05/2019
KT18133 04/20 12/12/2018
KT18194 07/20 01/15/2019
KT18129 02/20 05/25/18

Product Description: Equate Support Advanced Twin Pack W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19137 05/22 06/06/2019
19022 01/22 02/18/2019

Product Description: Equate Support Advanced Lubricating Eye Drops Dose Preservative Free W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill):

Lot Number Expiration Date Manufacturer Initial Ship Date
RKP 11/19 01/08/2018
RIN 09/19 12/22/2017
SLC 12/20 01/16/2019
RIF 09/19 10/10/2017
TBE 02/21 03/26/2019
TBI 02/21 05/15/2019
SHB 08/20 10/03/2018

Product Description: Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19015 01/21 02/06/2019
19117 04/21 05/20/2019
18080 07/20 08/02/2018
18111 05/20 05/25/2018

Product Description: Equate Support Moisture Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19011 01/21 04/01/2019
18052 02/20 03/26/2018
18266 10/20 01/15/2019
18178 07/20 08/20/2018
17385 12/19 01/24/2018

Product Description: Support Harmony Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.)

Lot Number Expiration Date Manufacturer Initial Ship Date
17290 09/19 11/03/2017

The products are manufactured and labeled exclusively for Wal-Mart. Altaire ships the products labeled for Wal-Mart only to Wal-Mart. The products are distributed at the retail level by Wal-Mart. Altaire has also requested that Wal-Mart notify its customers.

Altaire has notified Wal-Mart by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Altaire takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility.


Company Contact Information

Media:
Michael Sawaya, Joseph Sawaya
1-800-258-2471