Recalls / Class I
Class ID-0875-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Taytulla
- Generic name
- Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate
- NDC
- 0023-5862
- FDA application
- NDA204426
- Affected lot / code info
- Lot# 5620706, Exp. 05/19
Why it was recalled
Contraceptive Tablets Out of Sequence.
Recalling firm
- Firm
- Allergan, PLC.
- Manufacturer
- Allergan, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 Giralda Farms, N/A, Madison, New Jersey 07940-1027
Distribution
- Quantity
- 168,768 blister cards (4,725,504 softgel capsules)
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2018-05-24
- FDA classified
- 2018-06-15
- Posted by FDA
- 2018-06-20
- Terminated
- 2022-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0875-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.