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Home > Recalled Products > Drugs > Lack of Sterility > Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige Over-the-Counter (OTC) Ophthalmic Products

Recall: Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige Over-the-Counter (OTC) Ophthalmic Products

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On 2019-07-16, the FDA announced that Altaire Pharmaceuticals is conducting a recall on Over-the-Counter (OTC) Ophthalmic Products due to a possible . The recalled products were sold under the brand name(s) Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 9 drugs recalls due to potential lack of sterility, including otc and rx ophthalmic products, multiple ophthalmic products and more. Additionally, there have been 17 drug and medical device recalls due to other health hazards as well as 49 food recalls.

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Altaire Pharmaceuticals, Inc., Logo
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Company Contact Information:

Name: Altaire Pharmaceuticals

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Over-the-Counter (OTC) Ophthalmic Products

Brand Name(s): Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige

Reason for Recall: Lack of Sterility

Official Recall Date: 2019-07-16

Note: Although this recall announcement is dated 07/16/2019, it was not published by the FDA until 07/22/2019.



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  • Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige Summary Company Announcement Date: July 16, 2019 FDA Publish Date: July 16, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to lack of sterility assurance Company Name: Altaire Pharmaceuticals Inc. Brand Name: Brand Name(s) Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige Product Description: Product Description Over-The-Counter 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 by Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige Brands Inc., 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 the inventory of the distributors and retail outlets.

    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.

    ACCUTOME

    Product Description: Accutome Accu-WASH
    NDC# 63448-411-04 Product Size: 4 FL. OZ.

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16250 09/19 10/26/2016
    17088 03/20 09/27/2017
    17307 10/20 11/10/2017
    17323 10/20 12/27/2017
    18014 1/21 2/21/2018
    18228 9/21 10/29/2018
    18261 10/21 12/18/2018
    19119 4/22 6/3/2019

    FOCUS LABORATORIES

    Product Description: FreshKote Lubricant Eye Drops
    NDC# 15821-101-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    18095 4/20 5/15/2018

    GRANDALL DISTRIBUTING CO., INC.

    Product Description: Grandall Colirio Ojo De Aguila Eye Drops
    Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17131 5/20 8/7/2017
    18031 1/21 7/11/2018
    19065 3/22 5/2/2019

    Product Description: Grandall Colirio Oftal-Mycin Redness Relief Eye Drops
    Product Size: 15mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17008 01/20 2/2/2017

    Product Description: Grandall Oftal-Mycin Ophthalmic Ointment
    Product Size: 3.5 g

    Lot Number Expiration Date Manufacturer Initial Ship Date
    QJD 10/19 11/15/2016
    RFK 6/20 8/10/2017
    SCB 3/21 4/9/2018
    TBI 2/22 5/22/2019

    PRESTIGE

    Product Description: Clear Eyes Redness Relief
    UPC#: 6-78112-25415-6 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16195 7/19 8/9/2016
    16211 8/19 8/30/2016
    16216 8/19 9/8/2016

    Product Description: Clear Eyes Redness Relief
    UPC#: 6-78112-25419-4 Product Size: 30 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16205 7/19 8/16/2016
    16211 8/19 8/30/2016

    Product Description: Clear Eyes Redness Relief (Handy Pocket Pal)
    UPC#: 6-78112-15418-7 Product Size: 0.2 FL. Oz.

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16192 7/19 9/23/2016
    16203 7/19 10/14/2016
    16242 9/19 11/1/2016
    16280 10/19 11/7/2016
    16285 10/19 12/1/2016
    16300 11/19 12/15/2016
    16336 12/19 1/26/2017
    17002 1/20 2/3/2017
    17012 1/20 2/27/2017
    17051 2/20 3/30/2017
    17130 04/20 06/12/2017
    17147 05/20 08/29/2017

    Product Description: Clear Eyes Redness Relief (Little Drug)
    UPC#: 7-92554-70103-7 Product Size: 0.2 FL. Oz.

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16321 11/19 1/6/2017
    16336 12/19 1/26/2017
    17012 1/20 2/27/2017
    17034 2/20 3/9/2017
    17051 2/20 3/31/2017
    17147 5/20 8/29/2017

    Product Description: Clear Eyes Redness Relief (Select Corp)
    UPC#: 6-55708-01039-6 Product Size: 0.2 FL. Oz.

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16192 7/19 9/26/2016
    16203 7/19 10/14/2016
    16321 11/19 01/10/2017
    17002 1/20 2/6/2017
    17034 2/20 3/9/2017

    The above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively. The products are distributed at the retail level by the labelers identified herein. Altaire has also requested that the labelers each perform a subrecall.

    Altaire has notified Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige by e-mail on July 16, 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
    • Content current as of:

      07/16/2019

    • Regulated Product(s)
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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