Medicine recalls
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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple ophthalmic products sold by OCuSOFT |
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The US Food and Drug Administration (FDA) announces that Altaire Pharmaceuticals, Inc. is voluntarily recalling the prescription (Rx) and over the counter (OTC) drug products and lots, within expiry, sold by OCuSOFT. 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 inventory. 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 these products.
The affected products are:
- OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5% 5 mL
- OCuSOFT Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5% 15 mL
- OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution 15 mL
- OCuSOFT Tetravisc Forte 0.6 mL x 12 pcs
- OCuSOFT Tetravisc Forte 5 mL
- OCuSOFT Tetravisc 0.6 mL x 12 pcs
- OCuSOFT Tetravisc 5 mL
- OCuSOFT Flucaine 5 mL
- OCuSOFT Eye Wash 1fl oz
- OCuSOFT Eye Wash 4 fl oz
- OCuSOFT Tears Again Lubricant Eye Drops 15 mL
- OCuSOFT Tears Again Lubricant Eye Drops 30mL
- OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief 3.5g
- OCuSOFT retaine NaCl Ophthalmic Ointment 3.5g
- OCuSOFT retaine NaCl Ophthalmic Solution 15mL
Details of the affected products (including the lot numbers) are available in the FDA website.
The above products are labeled exclusively for OCuSOFT. Altaire ships the products labeled for OCuSOFT only to OCuSOFT. The products are distributed at the retail level by OCuSOFT. Altaire has also requested that OCuSOFT perform a subrecall.
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-multiple-ophthalmic-products-sold-ocusoft
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Jul 17, 2019
Issued at HKT 16:00
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