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  4. Altaire Issues Correction to 07.03.2019 Recall Announcement for OTC Products Sold at Wal-Mart
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COMPANY ANNOUNCEMENT

Altaire Issues Correction to 07.03.2019 Recall Announcement for OTC Products Sold at Wal-Mart

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
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 PAltaire 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 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. 

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.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 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. 

Original Recall


Company Contact Information

Consumers:
1-800-258-2471
otcdruggist@aol.com