Eye drops, eye ointments sold at Walmart and Walgreens recalled; Products may not be sterile
Altaire Pharmaceuticals, Inc., is voluntarily recalling eye drops and ointments sold at Walmart and Walgreens because they may not be sterile, according to a release on the FDA’s website.
As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency quality assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
So far, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including sterility testing, for the products.
Here is a list of the products at Walmart being recalled:
Product Description: Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL
| 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 |
| 19040 | 02/21 | 03/26/2019 |
Product Description: Equate Eye Allergy Relief Drops W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19128 | 05/21 | 06/20/2019 |
| 19009 | 01/21 | 01/28/2019 |
| 19003 | 01/21 | 02/21/2019 |
| 19034 | 01/21 | 03/07/2019 |
| 19060 | 02/21 | 04/22/2019 |
| 19061 | 02/21 | 05/21/2019 |
| 18252 | 10/20 | 11/21/2018 |
| 18058 | 03/20 | 03/22/2018 |
| 18224 | 09/20 | 09/26/2018 |
| 18185 | 07/20 | 08/27/2018 |
| 18152 | 06/20 | 07/05/2018 |
| 18159 | 06/20 | 07/18/2018 |
| 18091 | 04/20 | 06/07/2018 |
| 18090 | 04/20 | 04/27/2018 |
| 18069 | 03/20 | 04/04/2018 |
Product Description: Equate Sterile Lubricant Stye Ointment W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| SAJ | 01/21 | 03/23/2018 |
| SFE | 06/21 | 07/05/2018 |
| SIA | 09/21 | 10/23/2018 |
| RIE | 09/20 | 09/28/2017 |
| REH | 05/20 | 07/21/2017 |
| RAD | 01/20 | 05/23/2017 |
| TAH | 01/22 | 02/14/2019 |
| TDD | 04/22 | 05/29/2019 |
Product Description: Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL
|
Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17384 | 12/19 | 01/17/2018 |
| 17259 | 08/19 | 10/27/2017 |
| 19002 | 01/21 | 01/22/2019 |
| 19041 | 02/21 | 04/09/2019 |
| 18222 | 09/20 | 09/25/2018 |
| 18084 | 04/20 | 06/15/2018 |
Product Description: Equate Restore PM Nighttime Lubricant Eye Ointment W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram
|
Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| SKG | 08/21 | 12/18/2018 |
| SHK | 08/21 | 10/09/2018 |
| SHJ | 08/21 | 09/13/2018 |
| SEC | 05/21 | 07/13/2018 |
| SCB | 03/21 | 01/14/2019 |
| SBC | 02/21 | 03/21/2019 |
| RLB | 12/20 | 12/27/2017 |
| RBB | 02/20 | 04/28/2017 |
| RHR | 08/20 | 10/04/2017 |
| RFK | 06/20 | 07/28/2017 |
| RAB | 01/20 | 03/21/2017 |
| TAD | 01/22 | 01/25/2019 |
| TAQ | 01/22 | 03/18/2019 |
| TBI | 02/22 | 04/29/2019 |
| TDB | 04/22 | 06/07/2019 |
| QHE | 08/19 | 09/27/2016 |
| QJD | 10/19 | 12/07/2016 |
| SGE | 07/21 | 08/07/2018 |
Product Description: Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| KT19146 | 02/21 | 06/05/2019 |
| KT18133 | 04/20 | 12/12/2018 |
| KT18194 | 07/20 | 01/15/2019 |
| KT18129 | 02/20 | 05/25/18 |
Product Description: Equate Support Advanced Twin Pack W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 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):
|
Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| RKP | 11/19 | 01/08/2018 |
| RIN | 09/19 | 12/22/2017 |
| SLC | 12/20 | 01/16/2019 |
| RIF | 09/19 | 10/10/2017 |
| TBE | 02/21 | 03/26/2019 |
| TBI | 02/21 | 05/15/2019 |
| SHB | 08/20 | 10/03/2018 |
Product Description: Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL
|
Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19015 | 01/21 | 02/06/2019 |
| 19117 | 04/21 | 05/20/2019 |
| 18080 | 07/20 | 08/02/2018 |
| 18111 | 05/20 | 05/25/2018 |
Product Description: Equate Support Moisture Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19011 | 01/21 | 04/01/2019 |
| 18052 | 02/20 | 03/26/2018 |
| 18266 | 10/20 | 01/15/2019 |
| 18178 | 07/20 | 08/20/2018 |
| 17385 | 12/19 | 01/24/2018 |
Product Description: Support Harmony Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.)
|
Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 17290 | 09/19 | 11/03/2017 |
Here is a list of the products at Walgreens being recalled:
Product Description: Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19095 | 04/21 | 05/14/19 |
Product Description: Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19095 | 04/21 | 05/14/19 |
Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| TCI | 03/21 | 05/08/2019 |
Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| 19105 | 04/22 | 05/24/2019 |
| 19050 | 02/22 | 05/23/2019 |
Product Description: Lubricant Eye Ointment PF Soothing Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram
| Lot Number | Expiration Date | Manufacturer Initial Ship Date |
| TDB | 04/22 | 05/24/2019 |
“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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