Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Fabior (tazarotene)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Affected NDC
51862-0295-10
Compare with the code on your package — it is the most precise check available.
Drug: Tazarotene
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fabior tazarotene NDC 51862-0295 |
1 mg/g | Aerosol, Foam Topical |
Mayne Pharma | Rx |
- Recalling firm
- Mayne Pharma Inc
- NDC code
- 51862-295-10
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0616-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tazarotene recalls
See all
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Class II · Moderate risk
Tazorac (tazarotene)
Failed Content Uniformity Specifications.
Other recalls by Mayne Pharma Inc
All 2018 recalls
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class II · Moderate risk
Lexette (halobetasol propionate)
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
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