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Drug Recalls Management Protocol at LHDs

Understand the process of drug recalls at Local Health Departments, including review, removal, documentation, patient contact, and record-keeping guidelines.

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Drug Recalls Management Protocol at LHDs

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  1. Presentation #18 Drug Recalls

  2. 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

  3. 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.

  4. 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 on-site for at least two years following recall.

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