Recalls / Class III
Class IIID-0616-2018
Product
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
- Brand name
- Fabior
- Generic name
- Tazarotene
- Active ingredient
- Tazarotene
- Route
- Topical
- NDC
- 51862-295
- FDA application
- NDA202428
- Affected lot / code info
- Lot: MBEB, Exp. 01/31/2019
Why it was recalled
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Recalling firm
- Firm
- Mayne Pharma Inc
- Manufacturer
- Mayne Pharma
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1240 Sugg Pkwy, N/A, Greenville, North Carolina 27834-9006
Distribution
- Quantity
- 3312 cans
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-03-21
- FDA classified
- 2018-03-30
- Posted by FDA
- 2018-04-11
- Terminated
- 2020-06-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0616-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.