Drug_recalls

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Transcript Drug_recalls

Presentation #18
Drug Recalls
Drug Recalls
• Drug recalls must be reviewed by the
Department and forwarded to the
appropriate manager at the LHD.
• The manager shall arrange for removal of a
recalled drug and return it to the
manufacturer in accordance with the recall
instructions
Drug Recalls
• A copy of the recall letter must be returned
to the Department with either. . .
- Documentation that no such product is on
site.
-Documentation that the product was
returned to the supplier.
Drug Recalls
• Notation of a recall must also be made on
the Drug Inventory Log and retained for a
minimum of five years
• In the event of a Class I (patient level)
Recall, the manager must contact all
patients that received the affected lot
- The records documenting contact with
patients and returns shall be maintained onsite for at least two years following recall.