Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold By OCuSOFT
AQUEBOGUE, N.Y., July 15, 2019 /PRNewswire/ -- 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: OCuSOFT Tetcaine Hydrochloride Ophthalmic 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: OCuSOFT Goniosoft 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 retaine NaCl 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 retaine NaCl 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 [email protected] 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
SOURCE Altaire Pharmaceuticals, Inc.
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