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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 7.4 - SPECIAL RECALL SITUATIONS

7.4 - SPECIAL RECALL SITUATIONS
7.4.1 - General


7.4 - SPECIAL RECALL SITUATIONS


7.4.1 - General

There are several special recall situations which may require you to deviate from the normal recall procedures. Seek your supervisor's or R&E Coordinator's guidance on these. Examples include:

  1. Products in the possession of U.S. Defense Installations;
  2. NDA and NADA withdrawals;
  3. National Academy of Science (NAS)/Nuclear Regulatory Commission (NRC) (DESI) recalls of drugs judged ineffective; and
  4. Recalls involving jurisdiction of more than one Federal Agency (e.g., FDA/EPA, FDA/Consumer Product Safety Commission (CPSC), etc.).