Drug recall

Lorazepam Intensol Oral Concentrate USP, 2 mg per mL, 30 mL bottle and dropper, Rx only, Roxane Laboratories…

FDA recall event 30879 · Class II · Roxane Laboratories Inc

Key facts

Event ID 30879
Recall numbers D-150-5
Recalling firm Roxane Laboratories Inc
Product type Drugs
Products Lorazepam Intensol Oral Concentrate USP, 2 mg per mL, 30 mL bottle and dropper, Rx only, Roxane Laboratories, Inc., Columbus, OH ***** NDC 0054-3532-44
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall Degradation Failure; 3 month stability
Initiation date Jan 17, 2005
City Columbus
Country United States
FEI number 1510690

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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