Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Reason Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Content Uniformity Specifications.
Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Reason Failed Content Uniformity Specifications
Reason Failed Content Uniformity Specifications
Reason Failed Content Uniformity Specifications.
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