May 2018 FDA Recall Taytulla by Allergan, Plc.
D-0875-2018 - Contraceptive Tablets Out of Sequence.
This Class I drug recall was voluntarily initiated by Allergan, Plc. on May 24, 2018 for the product Taytulla. The FDA reported the reason for recall as contraceptive tablets out of sequence.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0875-2018
Contraceptive Tablets Out of Sequence.
05-24-2018
06-20-2018
168,768 blister cards (4,725,504 softgel capsules)
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Allergan, PLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide
05-19-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290
Batch or Lot Expiration Information
Lot# 5620706, Exp. 05/19
