The United States: Allergan issues nationwide voluntary recall of TAYTULLA® Softgel Capsules 1mg/20mcg sample packs due to out of sequence capsules (English Only)
 
The US Food and Drug Administration (FDA) announces that Allergan plc (NYSE:AGN) issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA®. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. 

As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician. 

The TAYTULLA® pill pack is a 28 count blister card that has 24 “active” pink softgel capsules (with hormones) with “WC” printed on the outer shell in white to be taken for 24 days, followed by 4 maroon softgel capsules (without hormones) also imprinted with “WC” on one side to be taken for the next four days. This product was distributed nationwide to healthcare providers. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm609044.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. 

Ends/Wednesday, May 30, 2018 
Issued at HKT 15:00 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/