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