Fabior Aerosol, Foam
FDA Recall NDC 51862-295
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fabior (NDC 51862-295). A significant event, classified as Class III, was initiated on Mar 21, 2018 by Mayne Pharma. The reported reason for this action was: "Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Mar 21, 2018
Apr 11, 2018
3312 cans
Recall Profile & Regulatory Data
Event ID
79604
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Mayne Pharma Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 11, 2020
Product Description
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Batch or Lot Expiration Information
Lot# Lot: MBEB, Exp. 01/31/2019
Affected Packages Involved in this Recall
51862-295-50Product
51862-295-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
