NEW YORK –
Allergan PLC issued a voluntary recall of a batch of Taytulla birth control in the US market.
Allergan recently identified through a medical report that four placebo capsules were out of service, a trial pack of Taytulla. In particular, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
The packs affected by the recall belong to Lot # 5620706, May-2019 expiration of Taytulla (norethindrone acetate and ethinylestradiol capsules and ferrous) fumarate capsules) 1mg / 20mcg, 6×28 Doctor's Sample Pack
Due As a result of this packaging error, oral contraceptive capsules which are not taken in the correct order may jeopardize the risk of contraceptive and unwanted pregnancy.
Order reversal may not be apparent to new users or previous users of the product, increasing the likelihood that the capsules will be taken out of service.
If patients are concerned about the possibility of accidental pregnancy, they should consult their doctor
The Taytulla pill pack is a 28-fold blister card with 24 "active" pink capsules (with hormones) on the outer shell of "WC" printed in white for 2 tablets is 4 days, followed by 4 chestnut softgel capsules (without hormones), which are also printed on one side with "WC" so that they can be taken for the next four days.
If you are a US patient who has used a Taytulla sample pack, Lot 5620706, Exp. May 201
Allegan informs customers through a recall letter and arranges for the return of all recalled sample packaging products with batch # 5620706 Exp. May 2019. Consumers who have the sample pack product with the associated lot number should notify their physician to arrange a return.
Consumers with questions about this recall can contact Allergan by phone at 800-678-1605 8:00 am to 8:00 pm EST Monday through Monday Friday. Consumers should contact their doctor or health care provider if they have any questions.
Adverse events or quality issues associated with the use of this product can be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by mail or by fax.
– Complete the report and submit it online: www.fda.gov/medwatch/report.htm
– Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request a form, then complete and return the address on the pre-addressed form or fax to 1-800-FDA-0178
This recall will be in accordance with the knowledge of the US American Food and Drug Administration (
More information about Taytulla and full prescribing information can be found on Taytulla.com
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