Medicine recalls
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| The United States: Altaire Pharmaceuticals, Inc. issues voluntary recall of multiple ophthalmic products sold at CVS |
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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 at CVS Health. 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 at the chain store.
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:
- CVS Health Natural Tears Lubricant Eye Drops Preservative Free 0.6 mL x 32 ct
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye 15 mL
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye 30 mL
- CVS Health Dry Eye Relief Eye Drops 15 mL
- CVS Health Dry Eye Relief Eye Drops 30 mL
- CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution 0.6 mL x 60 ct
- CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution 0.6 mL x 30 ct
- CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief 0.6 mL x 30
- CVS Health Lubricating Gel Drops for Anytime Use 10 mL
- CVS Health Overnight Lubricating Eye Ointment 3.5 gram
- CVS Health Lubricant Eye Ointment 3.5 gram
- CVS Health Extra Strength Lubricant Gel Drops 15 mL
- CVS Health Extra Strength Lubricant Gel Drops Twin Pack 2 x 15 mL
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy 15 mL
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack 2 x 10 mL
- CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution 0.6 mL x 30ct
- CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution 0.6 mL x 70ct
- CVS Health Preservative Free Lubricant Eye Drops Advanced Relief 0.6 mL x 30
- CVS Health Lubricant Eye Drops Advanced Relief 10 mL
- CVS Health Fast Acting Lubricant Eye Drops Preservative Free 0.6 mL x 24 ct
- CVS Health Preservative Free Lubricant Eye Drops Fast Acting 0.6 mL x 60 ct
- CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief 30 mL
- CVS Health Multi-Action Relief Drops 15 mL
- CVS Health Lubricant Eye Drops Lasting Dry Eye Relief 10 mL
- CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack 2 x 10 mL
- CVS Health Maximum Redness Relief Eye Drops 15 mL
- CVS Health Redness Relief 15 mL
- CVS Health Redness Relief 30 mL
- CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief 15 mL
- CVS Health Lubricant Eye Ointment Sensitive Formula 3.5 gram
Details of the affected products (including the lot numbers) are available in the FDA website.
The products are manufactured and labeled exclusively for CVS Health. Altaire ships the products labeled for CVS only to CVS. The products are distributed at the retail level by CVS.
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-cvs
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Jul 12, 2019
Issued at HKT 15:00
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