Here’s How Pharmaceutical Drugs Are Recalled. And Why Some Might Still Remain on the Shelves.

Everyone has read about or heard on their local news that this drug or that drug has been recalled for some reason or another. Usually, the manufacturer finds that. It’s usually something nefarious sounding like “DNA alternating carcinogens”, which is a scientific way of saying that in the worst case, the drug can kill healthy cells that lead to cancerous ones.

But who makes the decision to recall drugs, and what happens once medications from everyday thyroid pills to blood pressure meds don’t meet FDA standards?

The answer: pharmaceutical companies themselves. Those in charge of recalling medications are the ones who made them in the first place. In rare instances, the Food & Drug Administration (FDA) will recall a drug if some discrepancy was found during a manufacturing plant visit or via complaints from doctors or patients.  In the majority of instances, it is the drug maker that alerts the FDA, and the market, about its recall.

Late last month, Indian drug maker Aurobindo recalled two lots of a blood pressure medicine.  It alerted the FDA, as is standard procedure. It contained an above-allowable-limit carcinogen called N-Nitroso Quinapril.

Pfizer recalled the same drug for the same reason in April.

Consumers might think that the FDA would call for those particular lots to be pulled from pharmacies nationwide, but that is not the case. In this case, it is up to Aurobindo and Pfizer to advise the buyers of that particular lot of drugs, and the pharmacies and third-party administrations take it from there.  Doctors usually do not play a significant role at all in recalls.

Recalled drugs might remain on pharmacy shelves because pharmacists may sometimes consider a “voluntary recall” as voluntary and therefore not serious.

Moreover, action may not be taken right away. Patients often take these medications daily and may not even know about a recall, or get a replacement medication, until weeks after the fact, if ever.

The FDA’s role in a recall is “to oversee a company’s strategy, assess the adequacy of the recall and classify the recall,” they say.

The Aurobindo recall was a Class II recall. That’s defined as “a product that might cause a temporary health problem, or pose a slight threat of a serious nature.”

Class I is the most serious recall and Class III recalls are usually tied to mislabeling.

There is no official alert system that goes out to pharmacists and doctors from the FDA. The responsibility all rests with the manufacturer, so a trustworthy manufacturer with a clean record is paramount to ensuring safe drugs are on pharmacy shelves.

For its part, the FDA has banned Aurobindo drugs made in India before. Their “import alert” was lifted in 2018.

The FDA also issued Warning Letters to at least one Aurobindo manufacturing plant earlier this year. A Warning Letter is like a below-average grade for a  manufacturing plant following an inspection and can lead to the so-called Import Alerts, which are bans on product imports to the U.S.

Not all recalls garner media attention like the recent Aurobindo recall. The Miami Herald wrote about it on October 28.

Drug recalls happen regularly. The FDA alerts the public of the recalls, but it is the responsibility of the manufacturer to warn pharmacies and patients. Without FDA enforcement, though, millions of patients would be consuming tainted medication daily which can lead to health problems later on.

Public notification is usually only issued by the FDA in a Class I recall, when a defective product has been widely distributed and poses a serious health hazard that can lead to death. If a company does not issue public notification of a recall, the FDA may or may not act to warn the market, but only if they determine it is necessary to protect patients. Patients usually learn that their medicine has been recalled through notification from the manufacturer, their doctor or their pharmacist.

Medicines with voluntary recalls may not always be removed from pharmacy shelves.  This happened in 2008 when a blood thinner, heparin, from China was found to contain a potentially lethal contaminant. More than two hundred deaths were associated with the product. Months later, the recalled product was still found on some pharmacy shelves.

The FDA is an important actor here, however.

In 2019, lab tests of drugs used to control diabetes discovered a higher-than-allowed prevalence of nitrosamines.

No company recalled anything until six months later, in June 2020. Canadian manufacturer Apotex; Teva Pharmaceuticals of Israel and three Indian manufacturers  – Amneal, Lupin, and Marksans – all issued recalls on all of their lots, or only some lots. A month later, six more labs recalled the drug – known as extended-release metformin.

Aurobindo’s blood pressure medication recall in October is not their first recall. They issued a Class III voluntary recall of ibuprofen in November 2020.

In January 2020, they issued another Class III recall, this time on an anti-depressant called mirtazapine.

Recalls are almost always company-initiated. It is hard to know if they are followed through with buyers – the pharmacies and the doctors. It is harder to calculate how many drugs the FDA misses that are Class II violations. The 2019 metformin recalls serves as an example of the importance of a vigilant FDA.

“I was shocked and surprised to learn FDA has no authority to recall contaminated or unsafe drugs,” said Michael Stumo, CEO of CPA. That must change now that FDA has abdicated its authority to fully inspect Chinese and Indian manufacturers. Congress needs to fix this problem, and ignore the foreign-controlled generic drug lobby in the process.”