Call Your Doctor Now If You’re Taking This Medication, FDA Warns

Unlike the cold medicine or pain relievers you can buy over the counter at the pharmacy, prescription meds require your doctor’s signature before you can fill them. By speaking to a health professional and then pharmacist, you’re getting an extra level of safety by ensuring you won’t react negatively to the drug while also keeping an eye on any side effects or potentially dangerous interactions with other medicines. But now, the Food & Drug Administration (FDA) is warning patients taking one common medication that they should call their doctor immediately. Read on to find out which prescription could pose a potential health risk.

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Medications undergo a rigorous approval process before they can make their way to pharmacies and then into your cabinet, whether prescription or over the counter (OTC). However, recalls are sometimes necessary to keep the public safe when officials discover they can pose any kind of potential risk. In one such incident last month, the FDA announced that New Jersey-based Eugia US LLC had issued a voluntary recall for one lot of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single-dose vial, which is also known by the brand name Zovirax. The company said it pulled the drug after receiving a complaint that noted “the presence of dark red, brown, and black particulate inside the vial.”

That same week, the FDA announced another recall affecting Wonder Pill dietary supplements produced by the Proper Trade LLC-run My Stellar Lifestyle. The agency said the pills—which were marketed for use in male sexual enhancement and sold online by Walmart on its website—posed “serious health risks” to some people with underlying health conditions because they were tainted with tadalafil. Specifically, the ingredient could potentially interact with other prescription drugs such as nitroglycerin, leading to a “life-threatening” drop in blood pressure.

And on Sept. 29, the FDA announced that Golden State Medical Supply, Incorporated (GSMS, Inc.) had issued a voluntary recall for two of its prescription medications, Clopidogrel 75mg Tablets and Atenolol 25mg Tablets. In this case, the company said it pulled the products “out of an abundance of caution” after receiving a report that a bottle containing Clopidogrel 75mg Tablets was mislabeled as Atenolol 25mg Tablets, which could lead to serious health issues due to the incorrect dosage.ae0fcc31ae342fd3a1346ebb1f342fcb

Now, the agency has issued another warning that affects a prescription drug you may be taking for blood pressure.

On Oct. 24, the FDA announced that New Jersey-based Aurobindo Pharma USA, Inc. had issued a voluntary recall on two specific lots of its Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg. The affected products were first shipped out by the company in May 2021 to customers nationwide.

Pills that are part of the recall are packaged in plastic bottles stamped with the lot numbers QE2021005-A or QE2021010-A and have an expiration date of 01/2023. According to the agency’s notice, the tablets are “pink colored, scored, round-shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ’19’on other side.” The FDA says that quinapril and hydrochlorothiazide tablets are prescribed “for the treatment of hypertension, to lower blood pressure.”

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The company says it issued the recall after discovering the pills contained Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril.

According to the agency’s recall notice, nitrosamines are also commonly found in water and foods such as “cured and grilled meats, dairy products, and vegetables” at lower levels. However, the FDA warns that higher levels could increase the risk of cancer in people who are exposed to it at higher levels over a more extended period of time.

The FDA reports that so far, there have been no reports of adverse medical events related to the affected item. However, the agency says that anyone who has the recalled pills should immediately call their doctor or healthcare provider to determine whether they should keep taking the medication or “consider an alternative treatment prior to returning their medication.”

According to the agency’s notice, Qualanex will handle the recall on behalf of Aurobindo Pharma USA. The company says it will be contacting distributors and some customers by phone and in writing so they can begin requesting all affected accounts return the medications.

The FDA advises anyone who thinks they may have experienced adverse reactions as a result of taking the product to call their physician immediately. Those with further questions or concerns about the quinapril and hydrochlorothiazide recall can also reach Quanalex by calling the hotline or contacting the email address listed on the recall notice.