Summary

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Company Announcement

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. 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 received 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

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

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

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

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

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

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

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.

• 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.