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OCuSOFT Eye Products Recalled

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 […]

Ocusoft eye products recalled

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.

 

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