When adrug recalloccurs due totemperature excursions(exposure to temperatures outside the manufacturer’s recommended range during transport or storage), the pharmacy mustimmediately remove all affected productfrom its inventory to prevent dispensing compromised medication.
Remove the Affected Product:Quarantine the recalled drug to ensure it is not dispensed.
Verify the Recall Details:Confirm the lot number, expiration date, and reason for the recall using FDA or manufacturer recall notices.
Document the Recall Action:Log details in the pharmacy's recall records for compliance.
Follow Manufacturer or FDA Instructions:Some recalls require returning the product, while others require disposal according to hazardous waste guidelines.
Notify Patients and Providers (If Necessary):If the medication has already been dispensed, further action may be needed depending on recall severity.
B. Contact patients who received a therapeutically equivalent product.→ Incorrect. The recall applies to thespecificaffected lot, not all similar medications. Pharmacists would first verify which patients received the recalled drugbefore contacting them.
C. Switch patients from the oral solution to oral capsules.→ Incorrect. The recall does not automatically require a formulation change. The pharmacy must verify availability of unaffected stock or alternative treatments before making substitutions.
D. Contact all prescribers who recently prescribed the product.→ Incorrect. While prescribersmayneed notification if the recall affects patient treatment, thefirst stepis ensuring the recalled product is removed from stock to prevent further dispensing.
PTCB PTCE Exam Content Outline – Medication Safety and Recall Procedures.
FDA Drug Recall Guidelines (www.fda.gov).
USP <1079> Good Storage and Distribution Practices for Pharmaceuticals.
National Association of Boards of Pharmacy (NABP) Recall Compliance Standards.
Manufacturer Recall Notices (Example: Pfizer, Eli Lilly, etc.).
Mosby’s Pharmacy Technician: Principles and Practice – Recall Classifications and Actions.
Steps to Follow in a Drug Recall:Why the Other Answer Choices Are Incorrect:Pharmacy Technician References:
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