Allergan Taytulla Softgel Contraceptive Recall [US]


US FlagUS/Silver Spring: Taytulla Softgel Contraceptive Recall [US]Allergan plc, an Irvine, California establishment, recalls certain batch/lots of Taytulla Softgel Contraceptive (Birth Control) Capsules due to suspected presence of out-of-sequence Capsules and consequential risk of contraceptive failure and unintended pregnancy, all serious health and safety hazards.

FDA: http://ht.ly/oH2X30kfHEh

Direct link: https://www.fda.gov/Safety/Recalls/ucm609044.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Contraceptive Capsules are subject to this recall:

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. One (1) additional image of the recalled Taytulla Contraceptives can be found on the Web site above.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, Allergan has recalled certain batch/lots of Taytulla (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules) dosed at 1 mg/20 mcg, 6×28 Physicians Sample Packs, with a batch/lot designation of 5620706 and an expiry date of May 2019.

The recalled Contraceptives are indicated for use by women to prevent Pregnancy. Allergan recently identified, through a physician report, that four (4) placebo capsules were placed out of order in a sample pack of Taytulla. Specifically, the first four (4) days of therapy had four (4) non-hormonal placebo capsules instead of active capsules.

As a result of this packaging error, the recalled Oral Contraceptive Capsules are likely to be taken out of sequence order and may place the woman at a consequential risk for contraceptive failure and unintended Pregnancy. The out-of-sequence 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 you have concerns regarding the possibility of an unintended Pregnancy, please consult your physician.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug adulteration or contamination. If in doubt about the safety of any drug, return it to your physician, clinic or pharmacist for exchange.

==> To see other recalls and notifications caused by suspected Contraceptive failure hazard, please search for “contraceptive” or more generically, “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Allergan plc, please search for “Allergan” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Taytulla brand name, please search for “Taytulla” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 10239-2018
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General information:
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E. & O. E.

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