Packaging error leads to birth control pill recall in US

Packaging error leads to birth control pill recall in US

The recall issued in the USA market is 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.

The drugmaker on Tuesday said the physician sample packs of Taytulla were meant to have 24 active pink pills, followed by four inactive maroon capsules, taken daily for 28 days.

The physician reportedly placed the four maroon capsules in a sequence before the pink capsules. Allergan said that the incorrect order is significant enough to cause pregnancy. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.

Allergan announced the recall for Taytulla in a Tuesday, May 29 news release, with the U.S. Food and Drug Administration pushing out its own warning shortly after the news hit. Allergan provided a chart, below, outlining the pill packs in question. Modern birth control pills that are lower in estrogen have fewer side effects than past oral contraceptives. Those placebo pills have "WC" imprinted on them. Note the difference in locations of the darker colored pills.

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The manufacturer is concerned that users of their contraceptive may not notice the reversed order, thereby increasing the possibility of an unintended pregnancy. The company learned about the error after one physician reported it.

The recall applies to sample packs used since August 27, 2017, with the lot No. 5620706 and an expiration date of May 2019.

STAT points out this is just the latest negative news for Allergan so far this year.

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