Medicine recalls
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| The United States: Sandoz US Announces Voluntary Nationwide Recall of One Lot of Estarylla due to packaging flaw |
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FDA announced that Sandoz is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack. Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Sandoz is not aware of any reports to date of related adverse events. An internal medical assessment concludes that the probability of adverse health events is minimal, as the packaging flaw is easily visible and the risk of pregnancy occurring after non-administration of one blue tablet is low.
The recalled lot is LF01213A and it is supplied in cartons containing 3 blister cards of 28 tablets each. This lot was distributed to the US market only. Estarylla is manufactured for Sandoz by a third party manufacturer. In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm359613.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, July 04, 2013
Issued at HKT 12:00 |
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