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02-Jul-2019

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products

AQUEBOGUE, N.Y., July 2, 2019 /PRNewswire/ -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the prescription drug products and lots, within expiry, distributed during the time period as indicated in the tables below.  As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.  This recall is being carried out to the retail level and is only for the specific lots listed above. No other lots are being recalled. 

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.   To date, Altaire has receives no reports of adverse events, nor has Altaire obtained any out of specifications  results  including Sterility testing, for the products.

Product Description:  Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment NDC Number: 0574-4250-35 Package Size: 3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

SAC

1/20

1/29/2018

SLK

12/20

1/30/2019

Product Description: NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment NDC Number: 0574-4160-35 Package Size: 3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

RGC

7/19

8/7/2017

RHB

8/19

8/30/2017

RHC

8/19

8/30/2017

RID

9/19

10/2/2017

RIC

9/19

10/2/2017

RIG

9/19

10/23/17

RKH

11/19

12/8/2017

RKI

11/19

12/8/2017

RKJ

11/19

12/15/2017

RKK

11/19

12/15/2017

RKL

11/19

12/20/2017

RLM

12/19

1/29/2018

SAI

1/20

2/26/2018

SBG

2/20

3/12/2018

SBH

2/20

3/22/2018

SCF

3/20

4/23/2018

SEA

5/20

5/23/2018

SFA

6/20

6/20/2018

SFB

6/20

8/14/2018

SHA

8/20

8/30/2018

SIB

9/20

10/2/2018

SJC

10/20

11/9/2018

TAB

1/21

1/30/2019

TAF

1/21

2/18/2019

TBP

2/21

3/18/2019

TBQ

2/21

3/18/2019

TCV

3/21

5/1/2019

TCW

3/21

5/1/2019

Product Description: NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment  NDC Number: 0574-4144-35 Package Size: 3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

SEE

5/20

5/31/2018

SEG

5/20

7/13/2018

SIE

9/20

10/17/2018

SKD

11/20

12/27/2018

Product Description: POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment  NDC Number: 0574-4021-35 Package Size: 3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

RGD

7/19

8/17/2017

RHL

8/19

9/28/2017

RHB

9/19

10/23/2017

RJF

10/19

11/8/2017

RJG

10/19

11/7/2017

SAJ

1/20

2/12/2018

SAK

1/20

2/19/2018

SAL

1/20

2/19/2018

SAM

1/20

2/22/2018

SBK

2/20

3/22/2018

SEH

5/20

6/20/2018

TCD

3/21

5/1/2019

Product Description: Bacitracin Ophthalmic Ointment  NDC Number: 0574-4022-35 Package Size:3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

RGA

7/19

7/31/2017

RGE

7/19

8/11/2017

RGG

7/19

8/11/2017

RGH

7/19

8/17/2017

RHM

8/19

9/14/2017

RJB

10/19

10/23/2017

RJA

10/19

10/23/2017

SCA

3/20

3/22/2018

SIC

9/20

10/9/2018

TAP

1/21

2/26/2019

TDE

4/21

5/30/2019

Product Description: Sulfacetamide Sodium Ophthalmic Ointment  NDC Number: 0574-4190-35 Package Size: 3.5 gm

Lot Number

Expiration
Date

Manufacturer
Initial Ship
Date

RID

10/19

10/30/2017

SHG

8/20

9/13/2018

Product Description: Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product)

Lot Number

Expiration
Date

NDC Number

Package Size

Manufacturer
Initial Ship
Date

RJH

10/19

0574-4025-35

3.5 gm

11/13/2017

SCC

3/21

3/29/2018

SGA

7/21

7/31/2018

SGH

7/21

8/30/2018

SHH

8/21

9/13/2018

SLL

12/21

1/30/2019

TAC

1/22

2/18/2019

Lot Number

Expiration
Date

NDC Number

Package Size

Manufacturer
Initial Ship
Date

RKM

11/19

0574-4025-20

1 gm

12/8/2017

SGA

7/20

7/31/2018

SIF

9/20

10/17/2018

SKE

11/20

12/27/2018

The products are manufactured and labeled exclusively for Perrigo Company PLC.  Altaire ships the products only to Perrigo Company PLC.  The products are distributed by Perrigo Company PLC. 

Altaire has notified Perrigo by e-mail on July 2, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.  Altaire has also requested that Perrigo perform a subrecall, and that Perrigo notify its customers.

Customers with questions regarding this recall can contact 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.  Customers 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-300879559.html

SOURCE Altaire Pharmaceuticals, Inc.

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Last Updated: 02-Jul-2019