ketoconazole 20 mg per 1 g cream

Where the pills inside were made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants E. FOUGERA & CO., A division of Nycomed US Inc. names for other drugs.

Repackaging site

• RedPharm Drug, Eden Prairie, MN, United States · repackages it

Recalls

• Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
  cGMP deviations: Temperature abuse
  Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
• Nov 18, 2013 · Class III · Fougera Pharmaceuticals Inc.
  Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
  Lots: Lot #: 495P, Exp 07/14
• Jul 18, 2012 · Class III · Fougera Pharmaceuticals Inc.
  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
  Lots: Lot #: 835H, Exp 07/12

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Ketoconazole: every company that makes it

Form

cream

Strength

20 mg per 1 g

Approval

ANDA ANDA076294

On the market since

Apr 28, 2004

Package NDCs

67296-0448-1

Official label

DailyMed (National Library of Medicine), updated Jun 29, 2024

Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?