Ocusoft eye injury
AQUEBOGUE, NEW YORK – According to an online news article published by prnewswire.com, Altaire Pharmaceuticals, Inc. has voluntarily recalled some of its eye products sold by OCuSOFT.
Altaire Pharmaceuticals, Inc. has recently recalled many of its eye products amid concerns that some products may not be sterile. The latest recall involves both prescription and over-the-counter (OTC) eye products sold by OCuSOFT. According to Altaire, the voluntary recall of OCuSOFT eye products is precautionary, and there are no reports of patient injuries or deaths. Altaire has also stated that pursuant to testing, there have been no out-of-specification findings that any OCuSOFT products lacked sterility.
Altaire issued the latest recall following concerns with the Quality Assurance controls over critical systems in the manufacturing facility. The OCuSOFT recall is at the retail level and only applies to specific lots of OCuSOFT eye products. The recall applies only to products currently in inventory. The United States Food and Drug Administration (FDA) concluded that Quality Assurance issues indicate a lack of sterility assurance.
Specific OCuSOFT Eye Products Subject to Altaire’s Recent Recall
Altaire has provided the information in the tables below, identifying all OCuSOFT eye products subject to the recent recall. Each of these products was manufactured by Altaire and labeled exclusively for OCuSOFT and were only distributed to OCuSOFT. Altaire has requested that OCuSOFT initiate a sub-recall and inform all customers of the recall. All eye products that were purchased from OCuSOFT must be returned to OCuSOFT.
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 Tetracaine 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 Dangers of Exposure to Non-Sterile Products
Using a product that lacks sterility can be very serious and threatening to a person’s health. Many people exposed to non-sterile products may be perfectly fine and do not develop any injury or illness. However, if a person has a compromised immune system (including, among others, the elderly, children, and individuals with chronic medical conditions), he or she may develop an infection. Additionally, those with compromised immune systems may require extensive medical treatment to heal from an infection. In the most severe cases, a person may die from an infection spread by a non-sterile product.
New York | Brooklyn | Queens | Long Island | New Jersey | Florida
Call us at: 1-800-YOURLAWYER (800-968-7529) | Schedule your free consultation
Have you or a loved one been injured by an OcuSOFT eye products?
Click To Get A Free Case Review
