Drug recall

DESONIDE OINTMENT, 0.05%,15 grams per tube, Rx only, E. FOUGERA & CO., A division of Nycomed US Inc…

FDA recall event 59869 · Class III · Fougera Pharmaceuticals Inc.

Key facts

Event ID 59869
Recall numbers D-916-2011
Recalling firm Fougera Pharmaceuticals Inc.
Product type Drugs
Products DESONIDE OINTMENT, 0.05%,15 grams per tube, Rx only, E. FOUGERA & CO., A division of Nycomed US Inc., Melville, NY 11747, NDC 0168-0309-15, UPC 3 0168-0309-15 6.
Classification Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Container Leakage: Out-of-specification results for weight loss.
Initiation date May 3, 2011
Termination date Sep 28, 2012
City Melville
State NY
Country United States
FEI number 2432435

At a glance

  • 1–9 Products in this recall
  • 10–99 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports

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