Drug recall

Nizatidine Oral Capsules,150mg 60 ea per bottle.

FDA recall event 45914 · Class III · Apotex Inc.

Key facts

Event ID 45914
Recall numbers D-070-2008, D-071-2008
Recalling firm Apotex Inc.
Product type Drugs
Products Nizatidine Oral Capsules,150mg 60 ea per bottle., Nizatidine Oral Capsules, 300mg, 30 ea per bottle.
Classification Class III
Status Terminated
Voluntary or mandated Firm Initiated
Reason for recall Product failed stability test for related compounds.
Initiation date Nov 26, 2007
Termination date Dec 12, 2008
City Etobicoke
Country Canada
FEI number 3002808376

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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