Altaire Pharmaceuticals, Inc., announces that it is voluntarily recalling the Over-the-Counter drug products and lots, within expiry, 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.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 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 Contacts:
Michael Sawaya
Joseph Sawaya
1-800-258-2471
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SOURCE Altaire Pharmaceuticals, Inc.
