Grocery Pharmacy Drug Recall Response Log

Inspection log for documenting grocery pharmacy drug recall response actions, including affected NDC numbers, quarantine, inventory removal, patient notification, disposition, and corrective actions.

Inspection Details

• Recall notice identified and logged
  Confirm the recall notice has been received, reviewed, and entered into the recall response log.
• Recall identifier documented
  Enter the recall number, notice ID, or manufacturer recall reference.
• Inspection date and responsible pharmacist recorded
  Document when the recall response review was completed and who performed it.

Affected Product Identification

• Affected NDC numbers documented
  List all affected NDC numbers associated with the recall.
• Affected lot numbers documented
  Record the lot numbers included in the recall, if applicable.
• Expiration dates verified against recall scope
  Confirm expiration dates were checked against the recall notice and inventory records.
• On-hand quantity of affected product counted
  Enter the quantity of recalled product found in stock.
• Dispensed quantity identified from records
  Enter the quantity of recalled product previously dispensed to patients, if traceable.

Quarantine and Inventory Removal

• Affected stock removed from active inventory
  Confirm all identified recalled stock has been removed from saleable inventory.
• Recalled product placed in designated quarantine area
  Confirm recalled product is segregated in a clearly labeled quarantine location.
• Quarantine label applied
  Confirm the quarantined product is labeled with recall status, date, and responsible staff initials.
• Inventory system adjusted to prevent dispensing
  Confirm the pharmacy system has been updated to block or flag the recalled product.
• Physical segregation verified
  Confirm recalled stock is physically separated from non-recalled stock and not accessible to customers.

Patient and Prescriber Notification

• Affected patients identified from dispensing records
  Confirm the pharmacy reviewed dispensing records to identify potentially affected patients.
• Patient notification completed or attempted
  Document the notification status for affected patients.
• Prescriber notification completed or attempted
  Document whether prescribers were notified of the recall, if required by policy or recall severity.
• Patient contact method documented
  Select all methods used to contact affected patients.

Disposition and Corrective Actions

• Final disposition documented
  Record how the recalled product was handled at the end of the response process.
• Return or destruction documentation retained
  Confirm proof of return, destruction certificate, or equivalent disposition record is on file.
• Root cause or process gap identified
  Confirm whether a process gap, storage issue, or dispensing control issue contributed to the recall response risk.
• Corrective action documented
  Describe any corrective action taken, such as staff retraining, inventory system updates, or recall workflow changes.

Sign-Off and Reference

• Inspection comments and exceptions recorded
  Summarize any deficiencies, non-conformances, or open follow-up items.
• Reference document linked
  Enter the recall notice, SOP, or policy reference used for this response log.
• Inspector signature
  Signature of the pharmacist or authorized inspector completing the recall response log.