Altaire Pharmaceuticals, Inc. is expanding its voluntary recall of eye drops and eye ointments to those exclusively made for and sold at CVS, following concerns the products may not be sterile, the U.S. Food and Drug Administration announced.
The FDA had previously announced a voluntary recall of Altaire eye drops and eye ointments made for and sold exclusively at Walmart and Walgreens.
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.
So far, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results, including in-house and third party sterility testing, for the products.
Here is a list of the products being recalled:
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 |
“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,” the company said.
Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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