Generic Cholesterol Medication Recalled for Containing Glass Shards

There have been many recent reports of dangerous drugs, tainted medications, and products that just don't meet the high standards required for human use and consumption.  But this newest report certainly takes the cake.  Scanning the news this morning, the Wall Street Journal had an article that nearly made me choke on my coffee.

Ranbaxy Laboratories Ltd. is recalling 40 batches of its generic version of Lipitor, Atorvastatin, for glass shards they believe may be present in the medication. This is rather shocking news but the company has taken swift and decisive action to investigate how this could have happened, and have removed lots of the drug they feel may contain these minute glass shards.

Are Consumers at Risk?

According to the Wall Street Journal article, Ranbaxy Laboratories Ltd. is no stranger to manufacturing problems.  In January, the U.S. Justice Department alleged very serious problems with the company's manufacturing processes and entered a consent decree of permanent injunction  at the request of the U.S. Food and Drug Administration (FDA).  Although facilities manufacturing the Atorvastatin line were not included in this complaint, the DOJ consent decree alleges very serious flaws with the company's manufacturing processes, including:

  • failure to provide written evidence that drugs are being manufactured safely
  • failure to follow up on whether drugs complied with their specifications
  • failure to prevent cross- contamination of drugs such as anti-biotics, which could cause some people severe allergic reactions
  • failure to prevent contamination of medications
  • inadequate testing of medications
  • alleged falsified data
According to this decree, the company is inable to produce certain medications in the U.S. market until these manufacturing problems have been fixed.  Could this recent voluntary recall prohibit the company from producing generic Lipitor as well?

If You Have Been Harmed

When consumers obtain medication from their pharmacy, they have a reasonable expectation that these medications are safe for consumption.  Ranbaxy Laboratories Ltd. proactively recalled batches they thought contained the glass shards, but if other batches were similarly contaminated, consumers could find themselves at grave risk of injury and even death.  If you have been injured by one of these medications, it is important to seek immediate medical attention.  Injured consumers may also want to contact a skilled personal injury and product liability attorney as well to obtain compensation for these injuries.