Why it was recalled
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Product description
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Lot numbers, UPCs & expiration codes
Lot: MBEB, Exp. 01/31/2019
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0616-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 21, 2018
- FDA report date
- Apr 11, 2018
- Quantity
- 3312 cans
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Inc
Original FDA data
Every field from FDA enforcement report D-0616-2018, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 79604
- Address
- 1240 Sugg Pkwy
- Code information
- Lot: MBEB, Exp. 01/31/2019
- Postal code
- 27834-9006
- Report date
- Apr 11, 2018
- Product type
- Drugs
- Recall number
- D-0616-2018
- Classification
- Class III
- Recalling firm
- Mayne Pharma Inc
- Product quantity
- 3312 cans
- Termination date
- Jun 11, 2020
- Reason for recall
- Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2018