Fougera Pharmaceuticals, LLC
NDC labeler code: 0168
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 24, 2006 | ANDA077197 | Metronidazole METRONIDAZOLE | Fougera Pharms |
| May 28, 2004 | ANDA076408 | Metronidazole METRONIDAZOLE | Fougera Pharms |
| December 16, 1982 | ANDA088167 | Fluocinolone acetonide FLUOCINOLONE ACETONIDE | Fougera Pharms Inc |
| June 30, 1972 | ANDA080198 | Lidocaine LIDOCAINE | Fougera Pharms Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
April 13, 2022 · Class II · Terminated · D-1106-2022 · Triamcinolone acetonide
cGMP deviations: Temperature abuse
Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15
-
April 13, 2022 · Class II · Terminated · D-1047-2022 · Lidocaine and prilocaine
cGMP deviations: Temperature abuse
Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56
-
April 13, 2022 · Class II · Terminated · D-1065-2022 · Ketoconazole
cGMP deviations: Temperature abuse
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60
-
April 13, 2022 · Class II · Terminated · D-1028-2022 · Betamethasone dipropionate
cGMP deviations: Temperature abuse
Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46
-
April 13, 2022 · Class II · Terminated · D-1045-2022 · Hydrocortisone
cGMP deviations: Temperature abuse
Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30
2014
-
January 29, 2014 · Class III · Terminated · D-1152-2014 · Triamcinolone acetonide
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
2013
-
November 18, 2013 · Class III · Terminated · D-1044-2014 · Ketoconazole
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
2012
-
July 18, 2012 · Class III · Terminated · D-241-2013 · Ketoconazole
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026