Drug recall

Vivelle-Dot, Transdermal System, (estradiol) 0.1 mg, 8 systems per carton (retail), 2 units per carton…

FDA recall event 31474 · Class III · Novartis Pharmaceuticals Corp.

Key facts

Event ID 31474
Recall numbers D-257-5
Recalling firm Novartis Pharmaceuticals Corp.
Product type Drugs
Products Vivelle-Dot, Transdermal System, (estradiol) 0.1 mg, 8 systems per carton (retail), 2 units per carton (physician samples). Mfd. by Noven Pharmaceuticals, Inc., Miami, FL 33186. Dist. by: Novartis…
Classification Class III
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Stability Failure
Initiation date Mar 24, 2005
City East Hanover
Country United States
FEI number 2210396

At a glance

  • 1–9 Products in this recall
  • None 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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