Taytulla Kit
FDA Recall NDC 0023-5862
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Taytulla (NDC 0023-5862). A significant event, classified as Class I, was initiated on May 24, 2018 by Allergan, Inc.. The reported reason for this action was: "Contraceptive Tablets Out of Sequence."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Contraceptive Tablets Out of Sequence.
May 24, 2018
Jun 20, 2018
168,768 blister cards (4,725,504 softgel capsules)
Recall Profile & Regulatory Data
Event ID
80136
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Allergan, PLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
May 19, 2022
Product Description
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
Affected Packages Involved in this Recall
0023-5862-28Product
0023-5862-30Product
0023-5862-29Product
0023-5862-31Product
3002358622Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
