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Products Seized from Caraco Pharmaceutical Labs

By Oguz Ozdemir

After continued failure to adhere to the U.S. Food and Drug Administrations (FDA) Good Manufacturing Practice requirements, the U.S.Marshalls seized all of the drug products and materials that were found in the Caraco Pharmaceutical Labs Ltd. Caraco has three locations in Michigan – Detroit, Farmington Hills and Wixom. The Center for Drug Evaluation and Research is committed to protecting the public from companies who do not adhere to the safe and hygienic guidelines that are set by the FDA.

The company has enacted its own voluntary recalls of products since January 2009 as it became aware of inconsistencies in the production of some of its drugs. These inconsistencies were evident in some tablets that were oversized which in turn affected the correct dosage for effective treatment.

A warning letter was sent to Caraco on October 31, 2008 that discusses in detail all of the violations that this company is accused of and has ignored to date. Failure of quality control is elaborated on as serious inconsistencies in the production of drugs were discovered from the above mentioned facilities. Cross contamination of products was found, incorrect levels of certain medications that should be included in some of the medications were noted and failure to put certain products on hold because of manufacturing problems was also addressed.

The Caraco plants manufacture over 33 different drugs in a variety of strengths. The FDA seized all of the drugs as well as the ingredients that are used to produce the drugs. Of all of the products seized, the FDA is concerned that there could be a shortage of one of the products, choline magnesium trisalicylate which is used as a general pain reliever. The other medications are listed on the FDA site and are not expected to cause a shortage because of the confiscation as other pharmaceutical companies produce the same products.

Some of the more commonly used products manufactured by Caraco that have come under fire include Metformin, which is used by patients with type 2 diabetes to control blood sugar levels, Clozapine, which is administered as an anti-psychotic treatment for patients who suffer from schizophrenia, and Oxaprozin, which is used to treat inflammatory joint pain caused by osteoarthritis and rheumatoid arthritis.

Just the three examples listed above open up the possibility of complications as a result of the violations that have been confirmed at the Caraco manufacturing plants. Inconsistent doses that relate to any of the above conditions could result in serious side affects.

A diabetic who is not receiving a high enough dose or a too low dose of metformin can be affected directly through the effects it has on his or her blood sugar levels. An incorrect dose of medication that is administered to someone who is being treated for physcotic episodes could quickly become life threatening. And uncontrolled joint pain could be experienced by patients who suffer from both types of arthritis.

If you currently take or have taken in the past any medications manufactured by the Caraco companies, and have experienced any complications as a result, contact our law firm, Napoli, Bern Ripka, at 1-888-LAW-IN-NY. Our attorneys have experience in helping victims receive compensation for becoming victim to the negligence of major pharmaceutical manufacturers.

Originally posted at InjuryBoard by Oguz Ozdemir

Full post as published by New York City Personal Injury Lawyer on August 11, 2009 (boomark / email).