Medicine recalls
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| The United States: Mibelas 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc: Recall – Out of sequence tablets and missing expiry/lot information |
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The US Food and Drug Administration (FDA) announced a recall of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1mg/0.02mg chewable and ferrous fumarate 75mg) tablets (Lot: L600518, Exp: 05/18) by Lupin Pharmaceuticals Inc at consumer level. This product is an oral contraceptive indicated for the prevention of pregnancy in women who select to use oral contraceptives.
The product is packaged in blister packs containing 28 tablets: 24 white to off-white tablets of active ingredients debossed with “LU” on one side and “N81” on the other; and 4 tablets of inert ingredients debossed with “LU” on one side and “M22” on the other side. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets. As a result of this packaging error, oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm560908.htm
In Hong Kong, the above product is not a registered pharmaceutical product. There is also no registered pharmaceutical product which is manufactured by Lupin Pharmaceuticals Inc.
Ends/Wednesday, May 31, 2017
Issued at HKT 17:00
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