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Home > Recalled Products > Drugs > Lack of Sterility > OCuSOFT Prescription (RX) And Over-the-Counter (OTC) Ophthalmic Products

Recall: OCuSOFT Prescription (RX) And 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 Prescription (RX) And Over-the-Counter (OTC) Ophthalmic Products due to a possible . The recalled products were sold under the brand name(s) OCuSOFT 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: Prescription (RX) and Over-the-Counter (OTC) Ophthalmic products

Brand Name(s): OCuSOFT

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 Multiple Ophthalmic Products Sold by OCuSOFT Summary Company Announcement Date: July 15, 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) OCuSOFT Product Description: Product Description Prescription (RX) and Over-the-Counter (OTC) Ophthalmic products Company Announcement

    Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Prescription (RX) and Over-the-Counter (OTC) drug products and lots, within expiry, sold by OCuSOFT 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.

    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: OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5% NDC #: 54799-431-05 Product Size: 5 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17186

    6/20

    9/19/2017

    17345

    11/20

    1/12/2018

    19010

    1/22

    3/01/2019

    Product Description: OCuSOFTTetcaine HydrochlorideOphthalmic Solution USP, 0. 5%
    NDC #: 54799-502-15 Product Size: 15 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17205

    7/19

    9/19/2017

    17206

    7/19

    9/19/2017

    18003

    1/20

    2/21/2018

    18097

    4/20

    5/25/2018

    18166

    7/20

    9/10/2018

    18292

    11/20

    12/19/2018

    19106

    4/21

    6/13/2019

    Product Description: OCuSOFTGoniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution
    NDC #: 54799-503-15 Product Size: 15 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17303

    10/20

    12/21/2017

    18032

    2/21

    2/21/2018

    18235

    9/21

    10/29/2018

    18285

    11/21

    12/19/2018

    19021

    1/22

    3/01/2019

    Product Description: OCuSOFT Tetravisc Forte
    NDC #: 54799-504-01 Product Size: 0.6 mL x 12 pcs


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17217

    7/19

    11/10/2017

    18256

    10/20

    11/27/2018

    Product Description: OCuSOFT Tetravisc Forte
    NDC #: 54799-504-05 Product Size: 5 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17198

    7/19

    10/24/2017

    17199

    7/19

    10/24/2017

    17233

    8/19

    10/24/2017

    17337

    11/19

    12/21/2017

    17338

    11/19

    12/21/2017

    18248

    10/20

    11/27/2018

    Product Description: OCuSOFT Tetravisc
    NDC #: 54799-505-01 Product Size: 0.6 mL x 12 pcs


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17236

    8/19

    11/10/2017

    17334

    11/19

    12/21/2017

    18015

    1/20

    3/16/2018

    Product Description: OCuSOFT Tetravisc
    NDC #: 54799-505-05 Product Size: 5 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17232

    8/19

    10/24/2017

    17334

    11/19

    12/21/2017

    18249

    10/20

    11/27/2018

    19125

    4/21

    6/13/2019

    Product Description: OCuSOFT Flucaine
    NDC #: 54799-507-21 Product Size: 5 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17255

    8/20

    9/19/2017

    17362

    12/20

    12/21/2017

    18089

    4/21

    5/28/2018

    18138

    6/21

    6/22/2018

    18146

    6/21

    6/28/2018

    18210

    8/21

    9/10/2018

    18211

    8/21

    9/10/2018

    18272

    11/21

    11/27/2018

    18273

    11/21

    12/19/2018

    18276

    11/21

    12/19/2018

    Product Description: OCuSOFT Eye Wash
    NDC #: 54799-565-01 Product Size: 1fl oz


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    18026

    1/21

    2/21/2018

    18100

    4/21

    9/10/2018

    19052

    2/22

    4/10/2019

    19130

    5/22

    6/13/2019

    Product Description: OCuSOFT Eye Wash
    NDC #: 54799-565-59 Product Size: 4 fl oz


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    16268

    10/19

    11/07/2016

    16301

    11/19

    12/09/2016

    17088

    3/20

    4/28/2017

    17109

    4/20

    6/14/2017

    17318

    10/20

    11/10/2017

    17323

    10/20

    1/12/2018

    18014

    1/21

    2/21/2018

    18045

    2/21

    3/16/2018

    18059

    3/21

    5/25/2018

    18063

    3/21

    4/2/2018

    18117

    5/21

    6/22/2018

    18134

    5/21

    7/26/2018

    Product Description: OCuSOFT Tears Again Lubricant Eye Drops
    NDC #: 54799-904-15 Product Size: 15 mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17209

    7/21

    9/19/2017

    18168

    7/22

    7/26/2018

    18217

    8/22

    10/29/2018

    18260

    10/22

    11/27/2018

    19094

    4/23

    6/13/2019

    Product Description: OCuSOFT Tears Again Lubricant Eye Drops
    NDC #: 54799-904-30 Product Size: 30mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    17208

    7/21

    11/10/2017

    17209

    7/21

    11/10/2017

    19001

    1/23

    4/10/2019

    Product Description: OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief
    NDC #: 54799-906-35 Product Size: 3.5g


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    RHE

    8/20

    8/18/2017

    SCD

    3/21

    4/02/2018

    Product Description: OCuSOFT retaineNaCl Ophthalmic Ointment
    SKU #: 777-3-76 Product Size: 3.5g


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    SAP

    1/20

    3/16/2018

    SFI

    6/20

    10/29/2018

    TCI

    3/21

    6/13/2019

    Product Description: OCuSOFT retaineNaCl Ophthalmic Solution
    SKU #: 777-3-77 Product Size: 15mL


    Lot Number

    Expiration Date

    Manufacturer Initial Ship Date

    18008

    1/20

    6/22/2018

    19105

    4/22

    6/13/2019

    The above products are labeled exclusively for OCuSOFT. Altaire ships the products labeled for OCuSOFT only to OCuSOFT. The products are distributed at the retail level by OCuSOFT. Altaire has also requested that OCuSOFT perform a subrecall.

    Altaire has notified OCuSOFT by e-mail on July 15, 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: 1-800-258-2471 otcdruggist@aol.com Media: Michael Sawaya, Joseph Sawaya 1-800-258-2471
      • 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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