Pfizer Issues Medication Recall for Possibly Contaminated Relpax

medication recall, fda recall

Pharmaceutical company Pfizer has issued a medication recall for two lots of eletriptan hydrobromide because of potential contamination with bacteria.  Eletriptan hydrobromide sells under the brand name Relpax.  This recall is for the 40mg tablets of the drug.  Does the recall of this popular medication affect you?

Who is at Risk in this Medication Recall?

Relpax is used in the treatment of adults who suffer from migraines, with or without aura.  Anyone who regularly takes the 40mg dosage of this medication is at risk for illness due to the possible contamination.  According to the U.S. Food and Drug Administration (FDA), the bacteria that may be contaminating Relpax are varieties Pseudomonas and Burkholderia.

For most people, the risk of serious illness is low, but for certain vulnerable populations serious illness is certainly possible.  Populations that are most at risk for serious illness include:

  • Cystic fibrosis patients
  • Those with chronic granulomatous disease
  • All patients with compromised immune systems

For healthy adults, the risk is mainly temporary gastrointestinal distress.   For vulnerable populations, consuming pills contaminated with pathogens poses the risk of bacterial dissemination from the stomach into the bloodstream.  This can cause a serious and potentially life-threatening infection.

According to Pfizer, the company has received no reports of adverse events related to this medication recall.  However, the potential for contamination does not meet their internal quality standards, which is why they initiated the recall.

Relpax ships nationwide to wholesalers, retailers, hospitals, and healthcare providers.  Lots subject to the recall were distributed in the United States and Puerto Rico in June and July, 2019.

Details of the Relpax Medication Recall

Pfizer is working to remove this product from circulation, but the task is challenging.  With national distribution, this product reached consumers through pharmacies and doctors offices across the nation.  As a result, contaminated lots may still be available in those locations, as well as in patient homes.  That is why public awareness is vitally important to keep at-risk populations safe from the threat of non-sterile or contaminated pharmaceutical products.

Pfizer notified pharmacies and physicians via letter hoping to arrange the return of any remaining Relpax in the recall.  They request that doctors and pharmacists quarantine and return the products immediately .

Consumers, however, must rely on healthcare professionals to inform them about whether the Relpax in they take is part of the medication recall.   Pfizer will not be contacting consumers directly.   Consumers can identify the lots in the recall by the following:

  • Lot number AR5407, expires in February of 2022, carton containing six 40mg tablets in a blister pack.
  • Lot number CD4565, expires in February of 2022, carton containing 12 40mg tablets in two blister packs.

Patients who receive Relpax free through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), should be able to check their medication to determine if it is affected.  Any contaminated medicine should go to a healthcare provider instead of being thrown away.

Why Recalls Happen

Pharmaceutical drugs undergo rigorous testing for safety and effectiveness prior to becoming available for purchase by the consumer.  This process is managed by the FDA.  Once a pharmaceutical product is on the market, the FDA works with the manufacturer to continue to monitor the product for any unexpected problems.

When a problem does develop, such as bacterial contamination in this case, companies issue a medication recall and the FDA monitors it.  The top reasons a drug may be the subject of a recall include:

  • Health Hazards – Drug companies do not always identify all health risks and subsequent adverse effects possible until after the drugs are already on the market and widely in use.
  • Labeling Errors – It is extremely dangerous for consumers to take over-the-counter or prescription medications without realizing it.  If a patient believes the medication to be a certain product, but the label is wrong, adverse events are likely.  Though somewhat rare, mislabeled medication recalls can be very dangerous.
  • Manufacturing Defects – If a medication fails to meet either the pharmaceutical company’s internal quality standards or the FDA’s quality, purity, and potency standards, the product will likely be subject to a recall.

What Consumers Can Do About Medication Recalls

If you see a medication recall notice for a drug that you are taking, read the notice very carefully.  Recalls published by the FDA generally have instructions for consumers.   General practice for over-the-counter drugs is to stop taking the medicine immediately.  For pharmaceutical products, the FDA will make a recommendation based on the risk of stopping the medication versus the risk it poses to consumer health.

If one of your medications is subject to a recall and you have any concerns about your health, contact your healthcare provider.  You may be able to get an alternative medication right away or receive preventative treatment to curtail any damage the recalled medication may have already caused.

Medication Recall Tips to Keep in Mind

  • Don’t panic if the medication you take is the subject of a recall. Most drug recalls occur out of an abundance of caution.
  • Stay informed. There are many excellent sources to stay in the loop about the latest dangerous drug recalls.  Follow Drug and Device Watch for the information you need  to stay safe.
  • Don’t take chances with contaminated medicine. A healthy dose of caution can keep you from serious harm or injury.  Take seriously any recall notices you see that may affect your daily life, and act accordingly.
  • Discard recalled drugs safely. It is not a good idea to simply dispose of recalled pharmaceuticals in the trash in their pharmacy packaging.  Some drugs need to be put in coffee grounds or kitty litter before disposal.  Some pharmaceutical products should not be put in the trash at all.  Read FDA recall notices carefully to find out the best way to discard any recalled medicines.   When in doubt, contact your pharmacist who should be able to advise you.
  • Seek medical advice. If you have taken a drug subject to a medication recall, notify your healthcare provider.  Adverse effects sometimes take days or weeks to present themselves, and earlier treatment is better.
  • Talk to a lawyer if you needed medical care. If your adverse experience with recalled medication requires medical treatment, you need legal advice.

Contact Drug and Device Watch

It is natural to feel some level of anxiety and frustration if a medication you rely on is subject to a recall.  Your first goal is making sure that you are safe and your health is not in jeopardy.  If you have already suffered an injury or illness due to an unsafe medication, contact Drug and Device Watch.

Pharmaceutical companies should be accountable when their products cause you harm.  Find out what your legal rights are by calling our legal team at 1-888-458-6825.  You can also request more information by contacting us online.