A “musty odor” has led to a drug recall for somewhere in the neighborhood of 60,000 bottles of simvastatin produced by pharmaceutical company “Dr. Reddy’s.” Simvastatin is the generic name for the drug more commonly known as Zocor, which is prescribed for people trying to lower their cholesterol levels.
The musty odor has been linked to contaminants, namely trace amounts of a pesticide called “2,4,6-tribromoanisole,” also called “TBA.” The side effects of accidental TBA ingestion include possible gastrointestinal distress, but no cases of accidental ingestion or any condition requiring medical treatment have been reported.
Initiating a drug recall requires management of a variety of important information, including distribution range, providers, resellers, etc. Knowing the lot numbers of affected units is also vital. For this particular recall, a single lot of 500-count bottles containing 10 mg dosage pills was affected. Additionally, 6 lots of 40 mg / 90 count bottles were also recalled, along with 40 mg / 500 count bottles. Full lot numbers are available here. All affected units are reported to have come from the same “Dr. Reddy’s” production plant in Mexico.
This is not the first time Dr. Reddy’s has had to run a drug recall. In December of 2010 the company called back more than 25,000 bottles of simvastatin in 80 mg dosage amounts due to similar issues. No word if they came from the same plant in Mexico or not. “Offshoring” of pharmaceutical production can happen for many reasons, including less government regulation, or cheaper labor or materials. There’s no way to tell right now why or how the pills became contaminated, or if that could have been prevented had the factory been located in the US or some other location, but this drug recall does highlight the need to always obtain your medications from well-maintained, highly-inspected and reputable sources.
TBA is a fairly common common commercial/industrial pesticide, used mainly to treat wooden pallets. Dr. Reddy’s isn’t the only company that has had to issue a drug recall due to TBA contamination. Johnson & Johnson has had to take similar measures for its over-the-counter Tylenol products when they were found to be contaminated with the substance. Johnson & Johnson is no stranger to recalls of all kinds, running one of the largest OTC and consumer goods operations in the world. Their products are found inside almost every home.
Their subsidiary companies, some of which produce medical implants, manufacture products that can even be found inside some users walking around you – without you even knowing it. However, recently a Johnson & Johnson subsidiary called DePuy Orthopaedics performed a recall of a hip replacement product that they had released to market and ended up experiencing a higher-than-anticipated rate of failure. Their handling of the recall sparked some news interest when they retained a company that most often handled worker’s compensation and insurance claims to help administer compensation and medical coverage to those affected.
Dr. Reddy’s recall seems to be proceeding much more smoothly than the DePuy recall and no lawsuits or similar actions have been reported.
