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Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Over-The-Counter Ophthalmic Products Sold By Natural Ophthalmics And TRP Company, Inc.

AQUEBOGUE, N.Y., July 16, 2019 /PRNewswire/ -- 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.

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 Contacts:
Michael Sawaya
Joseph Sawaya
1-800-258-2471

 

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SOURCE Altaire Pharmaceuticals, Inc.