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Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold by OCuSOFT

Audience: Consumer, Health Professional, Pharmacy

July 16, 2019 -- 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 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.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 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.

Source: FDA

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