Altaire Pharmaceuticals, Inc., announces that it is voluntarily recalling the Over-the-Counter drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below.
AQUEBOGUE, N.Y., July 10, 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 CVS Health the during the time period as indicated in the tables below. 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 and IS ONLY FOR THE SPECIFIC LOTS LISTED BELOW. No other lots are being recalled. 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.
Product Description: CVS Health Natural Tears Lubricant Eye Drops Preservative Free
Item#: 538397 Product Size: 0.6 mL x 32 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| SEI | 5/21 | 06/20/2018 |
| SGC | 7/21 | 08/31/2018 |
| QGB | 07/19 | 09/06/2016 |
| QID | 09/19 | 11/11/2016 |
| RJC | 10/20 | 10/26/2017 |
| RCJ | 03/20 | 05/20/2017 |
| RCB | 03/20 | 03/24/2017 |
| TCJ | 03/22 | 06/03/2019 |
Product Description: CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye
Item#: 317916 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17196 | 08/19 | 10/13/2017 |
| 17192 | 09/19 | 11/14/2017 |
| 17355 | 11/19 | 12/22/2017 |
| 18024 | 01/20 | 02/27/2018 |
| 18036 | 02/20 | 03/26/2018 |
| 18237 | 09/20 | 10/31/2018 |
| 18293 | 12/20 | 12/27/2018 |
| 18105 | 04/20 | 06/06/2018 |
| 18179 | 07/20 | 08/08/2018 |
| 19040 | 2/21 | 03/26/2019 |
Product Description: CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye
Item#: 247887 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17222 | 07/19 | 09/28/2017 |
| 17386 | 12/19 | 01/15/2018 |
| 19018 | 01/21 | 03/14/2019 |
| 18016 | 01/20 | 02/19/2018 |
| 18181 | 07/20 | 08/27/2018 |
| 18104 | 04/20 | 06/08/2018 |
| 19018 | 1/21 | 06/04/2019 |
Product Description: CVS Health Dry Eye Relief Eye Drops
Item#: 317914 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17215 | 07/19 | 08/23/2017 |
| 17239 | 08/19 | 01/02/2018 |
| 18081 | 03/21 | 04/25/2018 |
| 18207 | 08/20 | 09/04/2018 |
| 18274 | 11/21 | 11/27/2018 |
Product Description: CVS Health Dry Eye Relief Eye Drops
Item#: 457802 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17277 | 09/19 | 10/20/2017 |
| 18006 | 01/20 | 02/22/2018 |
| 18098 | 04/21 | 02/04/2019 |
| 18006 | 1/20 | 05/30/2018 |
| 19057 | 02/22 | 03/29/2019 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 495334 Product Size: 0.6 mL x 60 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RGF | 07/19 | 08/10/29017 |
| RHN | 08/19 | 09/29/2017 |
| RIH | 09/19 | 10/30/2017 |
| RJP | 10/19 | 11/30/2017 |
| RKN | 11/19 | 12/11/2017 |
| SDC | 04/20 | 05/10/18 |
| SFC | 06/20 | 06/28/18 |
| SFJ | 06/20 | 07/25/18 |
| SGI | 07/20 | 09/18/18 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 994883 Product Size: 0. 6 mL x 30 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RGF | 07/19 | 08/10/2017 |
| RHN | 08/19 | 09/29/2017 |
| RIH | 09/19 | 10/23/2017 |
| RJP | 10/19 | 11/30/2017 |
| RKN | 11/19 | 12/11/2017 |
| SDC | 04/20 | 05/10/2018 |
| SFC | 06/20 | 06//28/2018 |
| SFJ | 06/20 | 07/25/2018 |
| SGI | 07/20 | 10/09/2018 |
| SKF | 11/20 | 01/04/2019 |
| TAE | 01/21 | 01/04/2019 |
Product Description: CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief
Item#: 634634 Product Size: 0.6 mL x 30
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| SEI | 5/20 | 06/20/2018 |
| TAK | 01/21 | 02/28/2019 |
Product Description: CVS Health Lubricating Gel Drops for Anytime Use
Item#: 563420 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17238 | 08/19 | 10/24/2017 |
| 18094 | 4/20 | 8/10/2018 |
| 19058 | 02/21 | 03/25/2019 |
Product Description: CVS Health Overnight Lubricating Eye Ointment
Item#: 881532 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RJK | 10/19 | 12/21/2017 |
| SBJ | 2/20 | 03/12/2018 |
| SFG | 6/20 | 07/19/2018 |
| SHI | 8/20 | 11/06/2018 |
| SLB | 12/20 | 02/01/2019 |
| TCM | 03/21 | 04/30/2019 |
| TDC | 4/21 | 03/20/2019 |
Product Description: CVS Health Lubricant Eye Ointment
Item#: 247881 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| SAS | 1/21 | 08/9/2018 |
| SIA | 9/21 | 02/28/2019 |
| SFE | 6/21 | 11/14/2018 |
| SAS | 1/21 | 08/9/2018 |
| SFE | 6/21 | 11/14/2018 |
| SIA | 9/21 | 02/28/2019 |
| RIE | 9/20 | 01/9/2018 |
| REH | 5/20 | 07/17/2018 |
| RAD | 1/20 | 05/4/2017 |
| TAH | 01/22 | 03/11/2019 |
Product Description: CVS Health Extra Strength Lubricant Gel Drops
Item#: 799143 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19087 | 3/21 | 04/26/2019 |
| 17289 | 9/19 | 12/19/2017 |
| 19087 | 03/21 | 04/26/2019 |
| 18122 | 5/20 | 11/19/2018 |
Product Description: CVS Health Extra Strength Lubricant Gel Drops Twin Pack
Item#: 258587 Product Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19087 | 03/21 | 05/29/2019 |
| 18122 | 5/20 | 11/19/2018 |
| 17289 | 9/19 | 04/20/2018 |
Product Description: CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy
Item#: 895160 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17223 | 07/19 | 09/26/2017 |
| 17297 | 10/19 | 11/17/2017 |
| 18017 | 01/20 | 02/05/2018 |
| 18018 | 01/20 | 02/21/2018 |
| 18065 | 03/21 | 06/08/2018 |
| 18213 | 08/20 | 09/11/18 |
| 18247 | 10/21 | 11/01/18 |
Product Description: CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack
Item#: 994881 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17296 | 10/19 | 07/23/2017 |
| 18094 | 04/20 | 05/11/2018 |
| 18206 | 08/20 | 09/06/2018 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 495301 Product Size: 0.6 mL x 30ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| QHI | 08/19 | 11/18/2016 |
| QJG | 10/19 | 12/6/2016 |
| RBA | 02/20 | 03/08/2017 |
| RCF | 03/20 | 04/11/2017 |
| RCM | 03/20 | 04/28/2017 |
| RDJ | 04/20 | 06/01/2017 |
| RFA | 06/20 | 06/20/2017 |
| RHI | 08/20 | 09/28/2017 |
| RJI | 10/20 | 11/16/2017 |
| RKG | 11/20 | 12/08/2017 |
| SBF | 2/21 | 06/6/2018 |
| SDD | 04/21 | 05/23/2018 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution
Item#: 457791 Product Size: 0.6 mL x 70ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| QHF | 08/19 | 10/20/2016 |
| QHI | 08/19 | 11/10/2016 |
| QLA | 12/19 | 01/05/2017 |
| RBA | 02/20 | 03/07/2017 |
| RCF | 03/20 | 04/11/2017 |
| RCM | 03/20 | 04/28/2017 |
| RDJ | 04/20 | 06/01/2017 |
| RFA | 06/20 | 06/21/2017 |
| RHI | 08/20 | 09/28/2017 |
| RJI | 10/20 | 11/16/2017 |
| RKG | 11/20 | 01/02/2018 |
| RLE | 12/20 | 01/02/2018 |
| SAE | 01/21 | 02/14/2018 |
| SBF | 02/21 | 04/11/2018 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Advanced Relief
Item#: 563442 Product Size: 0.6 mL x 30
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RJM | 10/19 | 11/22/2017 |
| RIA | 09/19 | 10/04/2017 |
| SAN | 01/20 | 02/22/2018 |
| SFF | 06/20 | 08/02/2018 |
Product Description: CVS Health Lubricant Eye Drops Advanced Relief
Item#: 563419 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17285 | 09/19 | 01/03/2018 |
| 18067 | 03/20 | 05/02/2018 |
| 18205 | 08/20 | 08/30/2018 |
| 18067 | 3/20 | 05/03/2018 |
Product Description: CVS Health Fast Acting Lubricant Eye Drops Preservative Free
Item#: 994882 Product Size: 0.6 mL x 24 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RIN | 09/19 | 10/23/2017 |
| RKP | 11/19 | 01/02/2018 |
| SAR | 01/20 | 03/07/2018 |
| SCG | 03/20 | 04/17/2018 |
| SED | 5/20 | 06/07/2018 |
| SLC | 12/20 | 01/18/2019 |
| TBE | 02/21 | 04/01/2019 |
| TBL | 02/21 | 05/15/2019 |
Product Description: CVS Health Preservative Free Lubricant Eye Drops Fast Acting
Item#: 258625 Product Size: 0.6 mL x 60 ct
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RHD | 08/19 | 08/29/2017 |
| RIF | 09/19 | 10/17/2017 |
| RIN | 09/19 | 10/23/2017 |
| RKP | 11/19 | 01/08/2018 |
| SAR | 01/20 | 02/21/2018 |
| SCG | 03/20 | 04/17/2018 |
| SED | 5/20 | 06/7/2018 |
Product Description: CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief
Item#: 799145 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17214 | 07/19 | 09/29/2017 |
| 18002 | 1/20 | 11/14/2018 |
| 18113 | 5/20 | 02/4/2019 |
Product Description: CVS Health Multi-Action Relief Drops
Item#: 694954 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 16267 | 10/19 | 11/07/2016 |
| 18096 | 04/21 | 08/01/2018 |
| 18301 | 12/21 | 12/27/2018 |
| 18096 | 4/21 | 06/14/2018 |
| 18301 | 12/21 | 12/27/2018 |
| 17371 | 12/20 | 01/19/2018 |
| 17158 | 6/20 | 06/26/2017 |
| 17025 | 1/20 | 04/21/2017 |
| 17015 | 1/20 | 02/08/2017 |
| 19103 | 04/22 | 06/03/2019 |
Product Description: CVS Health Lubricant Eye Drops Lasting Dry Eye Relief
Item#:968210 Product Size: 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17291 | 9/19 | 12/15/2017 |
| 17385 | 12/19 | 07/10/2018 |
| 18118 | 5/20 | 09/18/2018 |
| 18266 | 10/20 | 12/11/2018 |
Product Description: CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack
Item#: 495323 Product Size: 2 x 10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17291 | 9/19 | 12/19/2017 |
| 17385 | 12/19 | 03/23/2018 |
| 18118 | 5/20 | 08/17/2018 |
Product Description: CVS Health Maximum Redness Relief Eye Drops
Item#: 994880 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17251 | 8/19 | 09/05/2017 |
| 17269 | 9/19 | 11/09/17 |
| 17360 | 12/19 | 01/10/2018 |
| 18012 | 1/20 | 04/20/2018 |
| 18106 | 4/20 | 05/24/2018 |
| 18275 | 11/20 | 12/05/2018 |
| 18275 | 11/20 | 12/06/2018 |
Product Description: CVS Health Redness Relief
Item#: 317912 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 18229 | 9/21 | 10/12/18 |
| 18031 | 1/21 | 04/10/2018 |
| 17131 | 5/20 | 06/19/2017 |
| 17059 | 3/20 | 06/20/2017 |
| 17008 | 1/20 | 02/01/2017 |
| 19056 | 03/22 | 05/01/2019 |
Product Description: CVS Health Redness Relief
Item#: 457799 Product Size: 30 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 18229 | 9/21 | 11/02/2018 |
| 18229 | 9/21 | 06/04/2019 |
| 19056 | 03/22 | 04/17/2019 |
Product Description: CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief
Item#: 563431 Product Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 18043 | 2/20 | 03/16/2018 |
| 18115 | 5/20 | 08/06/2018 |
| 18300 | 12/20 | 02/01/2019 |
| 18300 | 12/20 | 02/01/2019 |
| 18116 | 5/20 | 02/01/2019 |
| 18115 | 5/20 | 06/11/2018 |
| 18044 | 2/20 | 05/30/2018 |
| 18043 | 2/20 | 03/16/2018 |
Product Description: CVS Health Lubricant Eye Ointment Sensitive Formula
Item#: 247885 Product Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| QHE | 08/19 | 11/11/2016 |
| QJD | 10/19 | 01/16/2017 |
The products are manufactured and labeled exclusively for CVS Health. Altaire ships the products labeled for CVS only to CVS. The products are distributed at the retail level by CVS.
Altaire has notified CVS by e-mail on July 10, 2019 announcing the recalls of the products/lots identified herein, 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.
- 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
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SOURCE Altaire Pharmaceuticals, Inc.
