Altaire Issues Correction To 07.03.2019 Recall Announcement For OTC Products Sold At Wal-Mart

Altaire Pharmaceuticals, Inc., announces that it is correcting its July 3, 2019 Announcement of a Voluntary Recall for Over-the-Counter drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below.

AQUEBOGUE, N.Y., July 15, 2019 /PRNewswire/ -- Altaire Pharmaceuticals, Inc., announces today that it is correcting its July 3, 2019 Announcement of a Voluntary Recall for Over-the-Counter (OTC) drug products and lots, within expiry, sold at Wal-Mart during the time period as indicated in the tables below.

Corrections are being made only for the products and lots as identified below; all corrections are explained immediately above the tables identifying the lot numbers and distribution dates for each applicable product No corrections are required for the other products and lots sold at Wal-Mart as identified in the 07.03.19 Notice of Recall.

As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

This recall is being carried out to the RETAIL LEVEL. A Retail Level recall is limited to product lots currently in inventory at the chain store.

Altaire further advises as follows:

TO DATE ALTAIRE HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS FOR THE PRODUCTS.

TO DATE ALTAIRE HAS NOT OBTAINED ANY OUT OF SPECIFICATIONS RESULTS, INCLUDING IN-HOUSE AND THIRD PARTY STERILITY TESTING, FOR THE PRODUCTS.

PRODUCTS REQUIRING CORRECTION:

  • Equate Restore Tears Lubricant Eye Drops Twin Pack mL (lots manufactured in 2018 have been added)
  • Equate Eye Allergy Relief Drops
  • Equate Sterile Lubricant Stye Ointment
  • Equate Support Advanced Twin Pack
  • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free
  • Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free

Please see tables below for corrected identification of impacted drug product lots and distribution dates:

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

Correction: lot numbers 18024, 18036, 18105, 18179, 18237 and 1829 which were inadvertently excluded are added to the recall.

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

18024

01/20

02/27/2018

18036

02/20

06/21/2018

18105

04/20

06/14/2018

18179

07/20

08/31/2018

18237

09/20

10/31/2018

18293

12/20

01/25/2019

19040

02/21

03/26/2019

Product Description: Equate Eye Allergy Relief Drops W-M item #: 567371432 NDC #: 49035-874-13 Package Size: 15 mL

Correction: NDC number has been corrected, lot numbers 18040 and 19033 which were inadvertently excluded are added to the recall, lot number 19003 has been removed [this product/lot number is not being recalled.)

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18040

02/20

03/08/2018

18050

02/20

05/02/2018

18058

03/20

03/22/2018

18069

03/20

04/04/2018

18090

04/20

04/27/2018

18091

04/20

06/07/2018

18152

06/20

07/05/2018

18159

06/20

07/18/2018

18185

07/20

08/27/2018

18224

09/20

09/26/2018

18252

10/20

11/21/2018

19009

01/21

01/28/2019

19033

01/21

02/21/2019

19034

01/21

03/07/2019

19060

02/21

04/22/2019

19061

02/21

05/21/2019

19128

05/21

06/20/2019

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

Correction: Lot number SAS which was inadvertently excluded is added to the recall, lot number SAJ has been removed [this product/lot number is not part of the Wal-Mart recall.)

Lot Number

Expiration Date

Manufacturer Initial Ship Date

RAD

01/20

05/23/2017

REH

05/20

07/21/2017

RIE

09/20

09/28/2017

SAS

01/21

03/23/2018

SFE

06/21

0705/2018

SIA

09/21

10/23/2018

TAH

01/22

02/14/2019

TDD

04/22

05/29/2019

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

Correction: lot numbers 18065, 18213 and 18247 which were inadvertently excluded are added to the recall.

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18065

03/21

06/26/2018

18213

08/20

09/01/2018

18247

10/21

11/07/2018

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)

Correction: lot number TBL which was inadvertently excluded is added to the recall; lot number TBI is removed from the list for Equate Support Advanced Preservative Free [Lot number TBI is Equate Restore PM Ointment, and is captured on the table for such product in the 07.03.19 Wal-Mart Notice of Recall.])

Lot Number

Expiration Date

Manufacturer Initial Ship Date

RIF

09/19

10/10/2017

RIN

09/19

12/22/2017

RKP

11/19

01/08/2018

SAR

01/20

02/19/2018

SCG

03/20

05/29/2018

SED

05/20

06/30/2018

SHB

08/20

10/03/2018

SLC

12/20

01/16/2019

TBE

02/21

03/26/2019

TBL

02/21

05/15/2019

Product Description: Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M item #: 567367998 NDC #: 49035-878-52 Package Size: 7.5 mL

Correction: NDC number has been corrected, lot number 18180 which was inadvertently excluded is added to the recall; lot number 18080 has been removed [this product/lot number is not part of the Wal-Mart recall.)

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18111

05/20

05/25/2018

18180

07/20

08/02/2018

19015

01/21

02/06/2019

19117

04/21

05/20/2019

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 notified Wal-Mart of the corrections by e-mail on July 15, 2019, with specific directions for return of all units of the impacted lots.

Any questions regarding this VOLUNTARY RECALL to the RETAIL LEVEL can be directed to 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.

Consumers 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 experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, 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 Contacts:
Michael Sawaya
Joseph Sawaya
1-800-258-2471

Cision View original content:http://www.prnewswire.com/news-releases/altaire-issues-correction-to-07-03-2019-recall-announcement-for-otc-products-sold-at-wal-mart-300885155.html

SOURCE Altaire Pharmaceuticals, Inc.

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