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Altaire Pharmaceuticals Recalls Ophthalmic Products

Altaire Pharmaceuticals Issues Voluntary Recall of Ophthalmic Products Amid Quality Assurance Concerns AQUEBOGUE, NEW YORK – According to an online news article published by www.prnewswire.com, Altaire Pharmaceuticals, Inc. has recalled multiple versions and lots of its ophthalmic products amid concerns that some products may not be sterile, posing a risk of infection to patients. Altaire […]

Altaire Pharmaceuticals Issues Voluntary Recall of Ophthalmic Products Amid Quality Assurance Concerns

Altaire Pharmaceuticals Recalls Ophthalmic Products Due to Lack of Sterility

Altaire pharmaceuticals recalls

AQUEBOGUE, NEW YORK – According to an online news article published by www.prnewswire.com, Altaire Pharmaceuticals, Inc. has recalled multiple versions and lots of its ophthalmic products amid concerns that some products may not be sterile, posing a risk of infection to patients.

Altaire Pharmaceuticals, Inc., with the knowledge of the United States Food and Drug Administration (FDA), recently issued a voluntary recall of numerous ophthalmic products that may have been sold and distributed to patients in a non-sterile condition.  While Altaire has not received any reports of injuries or infections related to non-sterile products, the company has discovered a problem in the manufacturing and quality assurance processes that may have resulted in some products being non-sterile.

All ophthalmic products subject to Altaire’s voluntary recall were manufactured and labeled exclusively for Perrigo Company PLC. Altaire ships all ophthalmic products to Perrigo and all products are distributed to customers by Perrigo. Altaire recently notified Perrigo of the recall with specific instructions to (1) return all affected products and lots to Altaire, (2) issue a sub-recall of the products, and (3) notify all customers of the recall.

Specific Ophthalmic Products Subject to Altaire’s Voluntary Recall

Altaire has provided a listing of all ophthalmic products which may have been non-sterile and therefore subject to the company’s recent voluntary recall.  Altaire provided the following product and lot information for all recalled products:

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

 

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

 

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

 

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

 

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

 

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

 

Puralube Ophthalmic Ointment (Over-the-Counter)

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

 

Consequences of Using Non-Sterile Products

The difference between a sterile and non-sterile product could mean the difference between life and death.  Patients who use non-sterile products may be exposed to harmful bacteria and other microorganisms.  While many infections are treatable if caught early on, such infections can quickly become life-threatening if a patient does not address the infection early on or has a compromised immune system which makes treatment more difficult (such as with the elderly, children, and individuals with chronic health conditions).  The same treatment for an infection caused by a non-sterile product may work in one patient, but not in another patient.  As such, ensuring products are sterile can prevent unnecessary illnesses and deaths.

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