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Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At Wal-Mart


News provided by

Altaire Pharmaceuticals, Inc.

Jul 03, 2019, 17:38 ET

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AQUEBOGUE, N.Y., July 3, 2019 /PRNewswire/ -- 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 [email protected] 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 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.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

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

SOURCE Altaire Pharmaceuticals, Inc.

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