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15-Jul-2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Manufactured and Distributed as Altaire Labeled Products

AQUEBOGUE, N.Y., July 15, 2019 /PRNewswire/ -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the over the counter (OTC) and prescription (Rx)  drug products and lots, within expiry, it has manufactured and distributed under the Altaire label and trade dress during the time period as indicated below.  As a precautionary measure, Altaire is voluntarily initiating this 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 on hand at any distributor to which Altaire Pharmaceuticals, Inc. has sold these products.

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 SPECIFICATION RESULTS, INCLUDING IN-HOUSE AND THIRD-PARTY STERILITY TESTING, FOR THESE PRODUCTS.

Product Description: ActivEyes Nighttime Lub Eye Ointment Preservative Free    NDC#: 59390-190-50   Product Size: 3.5 g 

Lot Number

Expiration Date

Manufacturer Initial Ship Date

SKG

11/21

12/28/2018

TAQ

01/22

04/23/2019

Product Description: Altaire Altacaine Solution     NDC#:  59390-181-13       Product Size: 15 mL   

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17205

07/19

08/31/2017

17206

07/19

09/13/2017

17271

09/19

11/08/2017

18003

01/20

03/06/2018

18097

04/20

05/11/2018

18166

07/20

07/26/2018

18227

09/20

10/05/2018

18246

10/20

11/16/2018

18317

12/20

12/18/2018

19080

03/21

04/22/2019

19106

04/21

05/21/2019

Product Description: ActivEyes Altachlore Ointment      NDC#:  59390-184-50    Product Size: 3.5 gram

Lot Number

Expiration Date

Manufacturer Initial Ship Date

SAP

1/20

3/16/2018

SFI

6/20

8/16/2018

SLA

12/20

1/4/2019

TBM

2/21

3/28/2019

Product Description: ActivEyes Altachlore Solution       NDC#:  59390-183-13       Product Size: 15 mL 

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18008

1/20

8/13/2018

19050

2/22

3/18/2019

19105

4/22

6/14/2019

Product Description: ActivEyes Altalube Ointment     NDC#:  59390-198-50     Product Size: 3.5 gram

Lo Number

Expiration Date

Manufacturer Initial Ship Date

RJH

10/20

1/10/2018

RLL

12/20

8/22/2018

SGH

07/21

8/23/2018

SIF

09/21

10/16/2018

SKC

11/21

12/12/2018

TCG

03/22

4/22/2019

Product Description:  Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%      NDC#:  59390-217-02  
Product Size:  2.5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18164

7/20

10/2/2018

Product Description: Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%     NDC#:  59390-217-05  
Product Size:  5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18164

7/20

8/15/2018

Product Description: Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3%     NDC#:  59390-217-10  
Product Size:  10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18164

7/20

8/15/2018

Product Description:  Altaire Diclofenac Sodium Solution 1%    NDC#:  59390-149-02     Product Size:  2.5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17247

8/19

11/17/2017

Product Description: Altaire  Diclofenac Sodium Solution 1%      NDC#:  59390-149-05  
Product Size:  5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17225

8/19

10/16/2017

17247

8/19

12/26/2017

18038

2/20

3/22/2018

18162

6/20

7/18/2018

19014

1/21

2/14/2019

Product Description: Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution
NDC#:  59390-205-05   Product Size:  5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17099

4/20

6/1/2017

17254

8/20

9/14/2017

17255

8/20

9/15/2017

17361

12/20

12/26/2017

17362

12/20

4/4/2018

18088

4/21

4/30/2018

18089

4/21

5/1/2018

18138

6/21

6/25/2018

18146

6/21

6/29/2018

18156

6/21

8/6/2018

18212

8/21

10/2/2018

18276

11/21

12/26/2018

19082

3/22

5/1/2019

19098

4/22

5/21/2019

16282

10/19

11/11/2016

16283

10/19

01/24/2016

Product Description: Altaire Eye Wash      NDC#:  59390-175-13       Product Size:  15 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17241

8/20

8/24/2017

17322

10/20

12/21/2017

18169

7/20

7/30/2018

19052

2/22

3/29/2019

Product Description: Altaire Eye Wash     NDC#:  59390-175-18        Product Size:  1 Fl. Oz.

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17200

7/19

7/28/2017

17322

10/20

11/27/2017

18026

1/21

3/5/2018

18100

4/21

6/18/2018

18236

9/21

11/1/2018

19052

2/22

3/22/2019

Product Description: Altaire Eye Wash      NDC#:  59390-175-35      Product Size:  4 Fl. Oz.

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17087

3/20

4/18/2017

17088

3/20

4/28/2017

17109

4/20

5/15/2017

17110

4/20

6/12/2017

17306

10/20

11/1/2017

17307

10/20

11/3/2017

17318

10/20

12/21/2017

17323

10/20

1/30/2018

18014

1/21

4/10/2018

18045

2/21

4/16/2018

18059

3/21

5/29/2018

18063

3/21

4/18/2018

18117

5/21

6/14/2018

18134

5/21

8/24/2018

18228

9/21

11/2/2018

18261

10/21

1/8/2019

19119

4/22

6/3/2019

16207

8/19

09/15/2016

16233

8/19

09/29/2016

16250

9/19

10/28/2016

16268

10/19

11/04/2016

16301

11/19

12/09/2016

Product Description: Altaire Goniotaire      NDC#:  59390-182-13        Product Size: 15 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17112

4/20

6/1/2017

17303

10/20

12/4/2017

18032

2/21

2/22/2018

18072

3/21

4/17/2018

18193

8/20

8/16/2018

18235

9/21

10/15/2018

18285

11/21

12/17/2018

19004

1/22

1/24/2019

19102

4/22

5/15/2019

16260

9/19

10/25/2016

Product Description: Altaire Homatropaire     NDC#:  59390-192-05        Product Size: 5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17041

2/20

6/01/2017

17186

6/20

11/10/2017

18068

3/21

8/17/2018

Product Description: NanoTears HA PF Multi Dose Lubricant Gel Drops     NDC#:  59390-208-10      Product Size: 10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

19122

4/21

5/31/2019

Product Description:  Nano Tears MO Clear Emollient Mineral Oil Lipids     NDC#:  59390- 145-10         Product Size:  10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18052

2/20

5/16/2018

Product Description: Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops
NDC#:  59390-144-10        Product Size: 10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17367

12/19

2/16/2018

18102

4/20

8/9/2018

18174

7/20

9/11/2018

Product Description:  Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack
NDC#:  59390-144-51         Product Size:  2 x 10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17367

12/19

5/16/2018

18174

7/20

8/24/2018

Product Description:  Nano Tears TF Clear Emollient  Tear Film Replenishment  Essential Lipids Preservative Free Multi-Dose      NDC#:  59390-141-52         Product Size:  7.5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

19123

4/21

6/07/2019

Product Description:  Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops
Preservative Free

NDC#:  59390-147-56         Product Size:  0.6 mL x 32 ct.

Lot Number

Expiration Date

Manufacturer Initial Ship Date

RGK

7/19

11/6/2017

SDA

4/20

4/27/2018

SFH

6/20

8/16/2018

TAN

1/21

5/23/2019

Product Description: Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free
NDC#:  59390-141-56      Product Size:  0.6 mL x 32 ct.

Lot Number

Expiration Date

Manufacturer Initial Ship Date

RGI

7/19

1/5/2018

SDB

4/20

5/16/2018

TAA

1/21

3/13/2019

Product Description: Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack
NDC#:  59390-142-49       Product Size:  2 x 15 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18033

2/20

8/10/2018

Product Description: Nano Tears TF Clear Emollient Lubricant Gel Drops       NDC#:  59390-142-13    Product Size: 15 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18033

2/20

06/04/2018

Product Description: Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack
NDC#:  59390-143-51    Product Size: 2 x 10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17366

12/19

1/31/2018

Product Description: Nano Tears XP Clear Emollient Lubricant Gel Drops 
NDC#:  59390-143-10    Product Size: 10 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17366

12/19

1/5/2018

18103

/20

7/9/2018

18173

7/20

8/3/2018

Product Description: Altaire Ofloxacin 0.3% Ophthalmic Solution USP
NDC#:  59390-140-05    Product Size: 5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

17244

8/19

10/9/2017

18057

3/20

5/15/2018

18307

12/20

1/9/2019

Product Description: ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF
NDC#:  59390-148-52      Product Size: 7.5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

19015

1/21

4/2/2019

Product Description: ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF
NDC#:  59390-146-52    Product Size: 7.5 mL

Lot Number

Expiration Date

Manufacturer Initial Ship Date

18099

4/20

4/2/2019

Product Description: ActivEyes Lubricant Eye Ointment Preservative Free      NDC#:  59390-189-50    Product Size: 3.5 gram

Lot Number

Expiration Date

Manufacturer Initial Ship Date

SFE

06/21

4/23/2019

The foregoing products are manufactured and labeled by Altaire Pharmaceuticals, Inc.   Altaire has notified all distributors 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.

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

 

View original content:http://www.prnewswire.com/news-releases/altaire-pharmaceuticals-inc-issues-voluntary-recall-of-multiple-ophthalmic-products-manufactured-and-distributed-as-altaire-labeled-products-300885183.html

SOURCE Altaire Pharmaceuticals, Inc.

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Last Updated: 15-Jul-2019