Key Takeaway

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10. by Mayne Pharma Inc was recalled on March 21, 2018. The hazard: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.

FDA Drug Class III Terminated

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Recalled: March 21, 2018 ~3312 cans units affected D-0616-2018

Description

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Hazard / Reason

Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.

Drugs

Company Information

Mayne Pharma Inc

Greenville, NC, United States

View all 6 recalls by Mayne Pharma Inc →

Distribution

Nationwide in the USA

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Frequently Asked Questions

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