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Home > Recalled Products > Drugs > Lack of Sterility > Natural Ophthalmics, TRP/Target Up & Up Over-The-Counter Ophthalmic Products

Recall: Natural Ophthalmics, TRP/Target Up & Up Over-The-Counter Ophthalmic Products

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On 2019-07-16, the FDA announced that Altaire Pharmaceuticals is conducting a recall on Over-The-Counter Ophthalmic Products due to a possible . The recalled products were sold under the brand name(s) Natural Ophthalmics and TRP/Target Up & Up 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 Ophthalmic Products

Brand Name(s): Natural Ophthalmics, TRP/Target Up & Up

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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Additional information provided by the FDA.gov:

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  • Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Over-The-Counter Ophthalmic Products Sold By Natural Ophthalmics And TRP Company, Inc. 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) Natural Ophthalmics, TRP/Target Up & Up 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 Natural Ophthalmics and TRP Company, 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 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.

    NATURAL OPHTHALMICS

    Product Description: Natural Ophthalmics Ortho-K Thick Comfort Gel
    NDC#: 68770-143-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17210 7/19 9/13/2017
    17378 12/19 2/12/2018
    18175 7/20 8/23/2018

    Product Description: Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops
    NDC#: 68770-103-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17281 9/19 11/28/2017
    18120 5/20 6/25/2018

    Product Description: Natural Ophthalmics Ortho-K Thin Eye Drops
    NDC#: 68770-144-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17375 12/19 2/12/2018
    17376 12/19 2/13/2018
    18190 7/20 8/23/2018
    18191 8/20 8/23/2018

    Product Description: Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops
    NDC#: 68770-104-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17374 12/19 2/12/2018
    18196 8/20 9/20/2018

    Product Description: Natural Ophthalmics Cataract Eye Drops with Cineraria
    NDC#: 68770-130-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17282 9/19 11/15/2017
    18121 5/20 6/25/2018

    Product Description: Natural Ophthalmics Allergy Desensitization Eye Drops
    NDC#: 68770-120-15 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    18114 5/20 5/18/2018

    TRP

    Product Description: TRP/ TARGET up & up intensive relief lubricating eye drop
    Item#: 31012 Product Size: 10 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17290 9/19 11/2/2017
    18052 2/20 4/20/2018

    Product Description: TRP Blur Relief
    NDC#: 17312-002-11 Product Size: 15 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    16256 09/19 11/16/2016
    17194 7/20 8/3/2017

    Product Description: TRP Stye Relief
    NDC#: 17312-014-13 Product Size: 4 g

    Lot Number Expiration Date Manufacturer Initial Ship Date
    RHP 8/19 10/13/2017
    RLD 12/19 1/26/2018
    SDE 4/20 5/14/2018
    SID 9/20 11/6/2018

    Product Description: TRP Pink Eye Relief
    NDC#: 17312-013-15 Product Size: 10 mL

    Lot Number Expiration Date Manufacturer Initial Ship Date
    17185 6/20 7/31/2017
    17228 7/20 10/23/2017
    17349 11/20 12/19/2017
    18073 3/21 5/23/2018
    18218 8/21 10/9/2018
    18303 12/21 1/21/2019

    The above products are labeled exclusively for Natural Ophthalmics and TRP Company, Inc. Altaire ships the products labeled for Natural Ophthalmics and TRP Company, Inc. only to Natural Ophthalmics and TRP Company, Inc., respectively. The products are distributed at the retail level.

    Altaire has notified Natural Ophthalmics and TRP Company, Inc. 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. v 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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