FDA Warns Canadian Pharmacy for Trying to Sell Unapproved Drug to Onfi Patients, Labeling Issues
The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011.
Additionally, the FDA called attention to the fact that the clobazam offered by Mark’s is misbranded because the labeling for the drug does not have adequate directions for use.
Further, the online purchases of the Canadian drug fail to include an FDA-approved med guide, required to be dispensed with Onfi.
Labeling remains one of the most intensely scrutinized aspects in agency inspections.
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