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  4. Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS

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
Over-the-Counter Drugs
Reason for Announcement:
Recall Reason Description
Due to lack of assurance of sterility
Company Name:
Altaire Pharmaceuticals, Inc
Brand Name:
Brand Name(s)
CVS Health
Product Description:
Product Description
Multiple Ophthalmic Products

Company Announcement

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.

  • 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.


Company Contact Information

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