Introduction

Companies such as Johnson & Johnson, Ranbaxy, and Ameridose are recalling many of their drug products due to FDA or consumer complaints. These companies have faced manufacturing issues leading to quality control problems of a facility, accusations of  “a pattern of systemic fraudulent conducts,” or a use of injectible products that are not sterile. In the case of Ranbaxy Pharmaceuticals, the recall of generic Lipitor provided new guidelines to pharmacies directing customers to stop taking the drug, but some pharmacies ignored the guidelines and continued to inform customers that it is safe to intake this drug. Are these companies focusing on regulating their manufacturing facilities enough?

Background
Many of the well-known companies, such as: Johnson & Johnson, who started out as a small business manufacturing sterile surgical supplies, and Ranbaxy, who is the 12th largest generic maker in the world, as well as Ameridose, who produces admixed preparations to hospital pharmacies, have developed consumer trust and loyalty. However, over the recent years these companies are facing some manufacturing issues concerning the safety of the drugs. As a result, companies need more time than expected to fix these manufacturing problems, causing a loss in consumer loyalty and trust as well as a delay in products returning to the market and causing a possible shortage.

Issue

When is there enough evidence to recall a drug?

Rule

In order to recall a drug, manufacturing facilities must fail in at least one of the following:

  1. Sterility testing processes
  2. Impurities
  3. Small particles of glass
  4. Musty, moldy smell and odor

Analysis

Johnson & Johnson recalled over 34,000 bottles of children’s Tylenol, Motrin, and Benadryl. The recalls started from a consumer’s complaint about a musty, moldy smell. The source of the problem was acknowledged in the McNeil manufacturing division, which led to more than 50 million bottles of Tylenol, Motrin, and Benadryl to be recalled. The moldy, musty odor was triggered by a trace of chemical called 2,4,6-tribromoanisole (TBA) and 2,4,6-trichloroanisole. This chemical is applied to wooden pallets to transport and store packaging material.

Further on, Johnson & Johnson recalled 57,000 bottles of Topamax, anti-seizure medication, for odor, which was triggered by TBA. The presence of TBA in Topamax caused some patients to experience temporary gastrointestinal symptoms. Once again, the recall was from the McNeil manufacturing facility. Johnson & Johnson’s attention to quality has declined over the years and they have experienced a dip in consumer trust.

Ranbaxy Pharmaceuticals recalled popular generic cholesterol drug, atorvastatin, which may be contaminated with small particles of glass. This drug is taken by roughly 3-4 million patients. It is considered a pharmacy-level recall, where pharmacies must stop providing patients with the drug, but consumers who already have this drug at home can continue to use it. The FDA indicated that the glass particles were “similar to the size of a grain of sand” and patients should contact their local pharmacies in order to see if the cholesterol drug has been contaminated, but the pharmacist have no way of knowing that information. The company has been accused of taking shortcuts in quality testing and fabricating data, not to mention importing 30 different drugs into the United States.

After an ongoing inspection by the FDA, Ameridose recalled all of their products due to issues with the sterility testing process. The process indicated possible hazardous outcomes for patients that could be life threatening. The recall of the products raises concerns for the hospitals, indicating that there may be a shortage of supply. Inspections indicated multiple possibilities of contamination near the pharmacy’s cleaning rooms and injections have been sent days after. In previous years, the FDA indicated that most of the drugs were shipped before they received the sterility test results, causing a recall on painkillers because they were too potent. Its sister company, the New England Compounding Center, has experienced 29 deaths due to their steroid medication. Both companies share some owners, so once one receives a bad reputation the other is not far behind.

Conclusion

In these instances, there is enough evidence to recall drugs. The quality of control went down as well as customer satisfaction, providing an incline in customer concerns and safety with certain drugs. The McNeil facility provided enough damage to make it easy for some Johnson & Johnson consumers to switch brands and loyalty. With Ranbaxy Pharmaceuticals’ unlawful characteristics of fabricating data and importing drugs to the U.S., consumers have every right to be concerned about their products and the FDA to acknowledge recalls. Due to previous recalls and issues with the sterility testing process, Ameridose made the right decision in recalling of all their products. It is best to keep patients at ease and far away until drug quality achieves FDA approval.

For more information on this issue, contact the Kulkarni Law Firm.