Drug recall

Aldara Cream, 5%, Cream (Imiquimod), Net Wt. 0.25 g per packet (12 single use packets per box) Manufactured by…

FDA recall event 38039 · Class III · Graceway Pharmaceuticals LLC

Key facts

Event ID 38039
Recall numbers D-819-2007
Recalling firm Graceway Pharmaceuticals LLC
Product type Drugs
Products Aldara Cream, 5%, Cream (Imiquimod), Net Wt. 0.25 g per packet (12 single use packets per box) Manufactured by 3M Health Care Limited, Loughborough LE11 1EP England, distributed by 3M Pharmaceuticals…
Classification Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Container Leakage; product packaging not properly sealed resulting in leaking.
Initiation date May 30, 2007
Termination date Apr 22, 2008
City Bristol
State TN
Country United States
FEI number 3006155916

At a glance

  • 1–9 Products in this recall
  • 1–9 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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