Drug Recalls

  • When a product has been determined to be a threat to public health a drug recall will be used and pulled off the market

  • Can be issued by the FDA or manufacturer

  • The FDA issues recalls when they receive multiple reports of adverse effects or misbranding. They then contact the manufacturer to issue a recalls.

  • Medwatch is The FDA Safety Information and Adverse Event Reporting Program. This is a voluntary reporting system that allows any healthcare professional or consumer to repot a serious adverse event associated with the use of any drug, biological device, or dietary supplement.

  • Reasons for a recall: Defective product, contamination, incorrect labeling, FDA interference, or improper production

  • The FDA determines the class of recall that is appropriate based on manufacturer actions, the healthcare situation, and consumer data from MedWatch and other sources

How the FDA Classifies Recalls

Class I: This is the most serious of the recall classes, exclusive to dangerous products that could cause serious health problems or death

  • Risk: Urgent, immediate danger

  • Action Response: Immediately notify all patients who received the product

  • Example: Some tablets are superpotent while other are subpotent

  • A 2014 recall of gabapentin. This medication is used to treat issues such as nerve pain caused by shingles or the herpes virus, restless leg syndrome, and seizures. A batch of the drug was recalled at the time because it was found that some empty capsules were in the lot, which would thereby lead to missed doses. As a result of the problem, patients taking the medication faced decreased effectiveness, as well as short-term withdrawals and potential seizures (if the drugs were being taken to prevent seizures).

Class II: Products might cause temporary or medically reversible health problems, but the likelihood of severe danger is remote

  • Risk: Intermediate, slight threat of a serious nature

  • Action Response: Pharmacist decides how and when to notify patients

  • Example: Packaging has incorrect or missing text or figures

  • Various batches of the injectable drug ketorolac were recalled in 2015 due to there being the possibility of tiny particles in the vials. Ketorolac is a non-steroidal anti-inflammatory drug used by people for short-term (no more than five days) to treat moderate to severe pain, including that felt after surgery. The FDA noted that the particulates found in the vials could potentially block the infusion of solution and delay therapy, however this delay was seen as one of negligible clinical significance.

Class III: These products are in violation of a law or regulation enforced by the FDA, but are unlikely to cause any adverse health problems

  • Risk: Least dangerous

  • Action Response: Pharmacist decides how and when to notify patients

  • Example: Children’s medicine contains cherry flavor instead of strawberry

What Happens When a Drug Recall Is Declared?

  • The manufacturer will issue a formal notice to the wholesalers, sellers, and customers; it will be marked “URGENT PRODUCT RECALL.” Important information about the recall will be provided as to why the recall has been issued. They will identify the product by description (name, dose, dosage form), NDC number, lot number and package size, expiration date.

  • Pharmacies have specific policies and procedures in place to ensure that the recalled drug is pulled from the shelves, documented and returned based on recall procedures. This includes notifying the manufacturer and the FDA of compliance with the removal of the recalled drug.

  • The pharmacy is required to contact affected patients in a Class I recall. In these cases the pharmacy or doctor’s office will contact the patient to check the lot number of dispensed medication a the media will be used to alert the public.

  • If a patient has the recalled drug they are asked to return the medication for replacement.

  • FDA market withdrawals can happen when a product has a minor violation that does not require legal action, but the product still must be removed from the market to correct the violation.

  • Recalled medications should be placed in a designated area until they are returned or disposed of as required by the recall notice.

  • The form is then returned to the wholesalers with any recalled drug stock items.

  • If the recalled product is not in stock, the pharmacy must still send the recall form back to the manufacturer.

  • Retail pharmacies generally have a return and refund policy in place when a company announces a product recall.