Class II · Moderate risk
Ketoconazole Cream
cGMP deviations: Temperature abuse
National Drug Code
Is NDC 0168-0099-60 recalled?
ketoconazole · 1 TUBE in 1 CARTON (0168-0099-60) / 60 g in 1 TUBE
Yes — this exact package was recalled
1 FDA recall names the code 0168-0099-60 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- ketoconazole
- Strength
- KETOCONAZOLE 20 mg/g
- Form
- Cream · Topical
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Type
- Human Prescription Drug
- Product code
- 0168-0099
Recalls naming this package
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class III · Low risk
Fougera Ketoconazole Cream 2%
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
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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