Drug product
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
D-0616-2018
Product summary
- Firm
- Mayne Pharma Inc
- Event
- Event 79604
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3312 cans
- Official record key
drug-enforcement:D-0616-2018
Official wording
Reason: Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Code information: Lot: MBEB, Exp. 01/31/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent