The FDA Safety Information and Adverse Event Reporting Program

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.

TOPIC: Multiple Ophthalmic Products by Altaire Pharmaceuticals Sold at Walgreens Stores: Recall – Due to Potential for Non-sterility

AUDIENCE: Consumer, Health Professional, Risk Manager, Pharmacy

ISSUE: Altaire Pharmaceuticals, Inc., announced on July 3, 2019 that it is voluntarily recalling the Over-the-Counter (OTC) drug products sold at Walgreens during the time period as indicated below:
• Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL. Lot Number 19095, Expiration Date: 04/21, Manufacturer Ship Date: 05/14/19.
• Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL. Lot Number 19095, Expiration Date: 04/21, Manufacturer Ship Date: 05/14/19.
• Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram. Lot Number TCI, Expiration Date: 03/21, Manufacturer Ship Date: 05/08/19.
• Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL. (Two Lot Numbers) (1) Lot Number 19105, Expiration Date: 04/22, Manufacturer Ship Date: 05/24/19 and (2) Lot Number 19050, Expiration Date: 02/22, Manufacturer Ship Date: 05/23/19.
• Lubricant Eye Ointment PF Soothing Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram. Lot Number TBD, Expiration Date: 04/22, Manufacturer Ship Date: 05/24/19.
The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.
Read Alert

One Response

  1. I love reading about the “adverse reporting” system…my own experience was so far beyond surreal that I lost any confidence I had in it. I was one of the first people to be put on Imitrex, back when it first came out in injectable form. While using it completely within guidelines, I experienced horrible, utterly debilitating swelling & agony in both wrists & forearms. My doctor took me off it & asked me to report it to the FDA & the manufacturer. What followed was insane: every time I called the FDA & manufacturer I had the most incredibly Kafkaesque conversations: they’d tell me that they’d never had a report of a similar problem, so they couldn’t take my report. I’d point out that if they never took the first report on a particular problem, they never would have a report of it. They repeated that they’d never had a report of a similar problem so they couldn’t take my report. This happened over & over until I thought I’d lose my mind. I tried writing them instead of calling, but this merely resulted in a form letter saying the same thing. I told my doctor, he tried to report it, & got the same result. Eventually I gave up.

    I still, after almost 30 years, have recurrent, agonizing wrist/hand attacks (& I lost a good job because of them), tho the frequency has decreased somewhat over the years. I’ve never touched Imitrex again in any form (other triptans “merely” caused uncontrollable vomiting). But as far as I know, there’s no report of Imitrex possibly causing joint damage. It’s slightly possible that I suffered from an obscure virus & that caused the problem, not the Imitrex, but since neither the FDA nor the manufacturer would take the first report, I suppose no one will ever know if anyone else suffered similar problems from it. Grrrrreat system.

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