FDA Recall D-0875-2018

Allergan, PLC. · Madison, NJ

Class I — life-threatening Terminated 1456 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Lot# 5620706, Exp. 05/19

Quantity: 168,768 blister cards (4,725,504 softgel capsules)

Reason for recall

Contraceptive Tablets Out of Sequence.

Recall record

Recall number: D-0875-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide
Recall initiated: 2018-05-24
Classified by FDA Center: 2018-06-15
FDA published: 2018-06-20
Terminated: 2022-05-19
Recalling firm: Allergan, PLC.
Firm location: Madison, NJ

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