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.
Read AnnouncementSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
Over-the-Counter Drugs - Reason for Announcement:
-
Recall Reason DescriptionDue to lack of assurance of sterility
- Company Name:
- Altaire Pharmaceuticals, Inc
- Brand Name:
-
Brand Name(s)CVS Health
- Product Description:
-
Product DescriptionMultiple 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