D-0616-2018 Class III Terminated
FDA drug recall D-0616-2018 was initiated by Mayne Pharma Inc on Mar 21, 2018 and is designated Class III. Reason for recall: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point. The recall status is terminated (terminated Jun 11, 2020). Affected quantity: 3312 cans.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 11, 2018
- Initiation Date
- Mar 21, 2018
- Termination Date
- Jun 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3312 cans
Product Description
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Reason for Recall
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: MBEB, Exp. 01/31/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0616-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026