Summary
- Company Announcement Date:
- July 15, 2019
- FDA Publish Date:
- July 15, 2019
- 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.
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