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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of Over-the-Counter ophthalmic products sold by Natural Ophthalmics and TRP Company, Inc. (English only) |
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The US Food and Drug Administration (FDA) announces that Altaire Pharmaceuticals, Inc. is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold by Natural Ophthalmics and TRP Company, Inc. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of quality assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
This recall is being carried out to the retail level and is only for the specific lots. No other lots are being recalled. A retail level recall is limited to product lots currently in the inventory of the distributors and retail outlets. Altaire further advises as follows:
- To date Altaire has not received any reports of adverse events for the products.
- To date Altaire has not obtained any out of specification results, including in-house and third party sterility testing, for the products.
The affected products are:
Natural Ophthalmics
- Natural Ophthalmics Ortho-K Thick Comfort Gel 15 mL
- Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops 15 mL
- Natural Ophthalmics Ortho-K Thin Eye Drops 15 mL
- Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops 15 mL
- Natural Ophthalmics Cataract Eye Drops with Cineraria 15 mL
- Natural Ophthalmics Allergy Desensitization Eye Drops 15 mL
TRP
- TRP/ TARGET up & up intensive relief lubricating eye drop 10 mL
- TRP Blur Relief 15 mL
- TRP Stye Relief 4 g
- TRP Pink Eye Relief 10 mL
Details of the affected products (including the lot numbers) are available in the FDA website.
The above products are labeled exclusively for Natural Ophthalmics and TRP Company, Inc. Altaire ships the products labeled for Natural Ophthalmics and TRP Company, Inc. only to Natural Ophthalmics and TRP Company, Inc., respectively. The products are distributed at the retail level.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-over-counter-ophthalmic-products-sold-natural
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Jul 18, 2019
Issued at HKT 17:00
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