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Even before they expire, there are potential problems with the quality of some CVS over-the-counter medications. CVS brand over-the-counter drugs (also called “private label”) are twice as profitable for the company as sales of national brands,  and CVS touts them as high quality economical alternatives to national brands.

CVS sources production of some of its private-label over-the-counter medications to companies that manufacture products or buy active ingredients in India and China.  However, CVS has failed to act aggressively after regulators have found quality problems at an Indian drug maker, Ranbaxy, that makes CVS brand products, as described below. And CVS apparently has no policy against the use of Chinese-produced active ingredients in its private-label medicines, despite a string of scandals tied to contaminated Chinese products.  

CVS’s Slow Response to Quality Lapses

In September 2008, the FDA issued an import alert for drugs from two Indian factories run by the company Ranbaxy, at which the FDA had found "serious manufacturing deficiencies" including cross-contamination between different drugs and inadequate sterilization.   Under an "import alert," U.S. officials may prevent all drugs covered by the alert from entering the U.S. CVS did not take aggressive steps in response, such as pulling Ranbaxy products from its shelves. Two of the Ranbaxy drugs covered in the FDA’s import alert have been sold as CVS brand products with packaging indicating that they were made by Ranbaxy.  They are loratadine (generic Claritin or generic Alavert) and ranitidine (a generic version of the heartburn drug Zantac).  CVS has also sold a Ranbaxy-produced CVS brand version of the formerly prescription antihistamine Zyrtec.  

CVS has had problems with Ranbaxy’s quality control on private label drugs it produced for CVS as far back as February 2007. At that time Ranbaxy recalled children’s loratadine syrup (generic Claritin) – including CVS brand children’s loratadine syrup – because the drug “[e]xceeded impurity specification.”   

Over the last several years, the mounting problems at Ranbaxy should have been impossible for CVS to ignore:

• In June 2006, FDA inspectors issued a warning letter (PDF) citing poor stability testing practices at a Ranbaxy factory.
  
  
• In 2007, Ranbaxy had to recall 73 million Gabapentin tablets, an anti-seizure drug produced at the same factory that the FDA had cited for violations in 2006.
  
  
• In July 2008 the Justice Department accused Ranbaxy of “systematic fraudulent conduct, including submissions by Ranbaxy to the FDA that contain false and fabricated information about stability and bioequivalence, failure to timely report the distribution of drugs that were out of specification (“OOS”), and attempts to conceal violations of current Good Manufacturing Practices (cGMP) regulations from the FDA.”
  
  
• In connection with the Import Alert referred to above, in September 2008, the FDA issued two warning letters, one for the factory it had warned in 2006 and one for another Ranbaxy facility, citing quality control problems including cross-contamination between different drugs and inadequate sterilization.  

“My advice to my pharmacists is we better stop dispensing this stuff,” the incoming president of the National Community Pharmacists Association, said of Ranbaxy products.  Instead of more aggressive and decisive steps, after two years of FDA problems with Ranbaxy, CVS told a reporter in September 2008 that it was “identifying alternative supplier arrangements to maintain our product supply for the select items affected by the FDA action.”  Ranbaxy-produced CVS Brand over-the-counter products remained on at least some CVS shelves as of November 2008.  

CVS Brand: Record of Problems

Ranbaxy is only the latest example of the problems that arise from CVS’s sourcing the production of CVS brand over-the-counter (“OTC”) drugs:

• Leiner Health, a producer of CVS brand OTC medications, shut down manufacturing operations at one of its plants in 2007 after the FDA accused the company of committing fraud by falsifying safety and purity tests.
  
  
• CVS Brand acetaminophen was recalled in 2006 when it was found to contain metal fragments.  This product was made by Perrigo, which buys large volumes of acetaminophen (generic Tylenol) and other pharmaceutical ingredients from China, according to U.S. Customs data and Perrigo’s website.
  
  
• CVS nicotine gum has been recalled twice: in 2005 because of “Degradation Failure” and in 2003 because it contained pieces of latex gloves.
  
  
• CVS Antacid Liquid Antacid/Antigas (Aluminum hydroxide, Magnesium hydroxide, Simethicone) was recalled in 2006 because it was "[s]ubpotent."
  
  
• In 2001, three companies that produced or later produced CVS brand OTC drugs settled Federal Trade Commission charges that they had falsely labeled their products “Made in USA,” when the active ingredients had been made overseas. The producers were Perrigo, Leiner and LNK International.