Allergan has voluntarily recalled a single lot of its norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules (Taytulla) physician sample packs because of incorrect placement of inactive placebo pills in the packs.
|Recalled Lot||Product||NDC||Size||Exp Date|
Taytulla softgel capsules
1 mg/20 mcg
6 x 28 sample
Outer carton 0023-5862-31
Blister card 0023-5862-28
Blister box 0023-5862-29EN1216XX2
|6 x 28 Sample||May 2019|
Through a physician report, Allergan found that four placebo capsules were out of order in a sample pack of Taytulla. The first 4 days of therapy had four inactive nonhormonal placebo capsules instead of active capsules, according to the company announcement posted May 29 on the US Food and Drug Administration (FDA) website.
"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," the company said.
The recalled lot includes roughly 170,000 packs of Taytulla, according to media reports. The product was distributed across the United States.
Allergan is notifying customers by recall letter and arranging for return of all recalled product. The company is advising women who have used a Taytulla sample pack from the recalled lot to consult with their physician if they are concerned they may be affected by this issue.
Anyone with questions regarding this recall may contact Allergan at 800-678-1605, 8 AM through 8 PM ET, Monday through Friday.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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Cite this: Megan Brooks. Taytulla Birth Control Pills Recalled Due to Packaging Error - Medscape - May 29, 2018.