Arkansas pharmacy at the center of a federal investigation for manufacturing and distributing adulterated drugs.
The United States filed a civil complaint and a motion seeking a preliminary injunction against Cantrell Drug Company and its co-owner and Chief Executive Officer, James L. McCarley Jr., to stop the manufacturing and distribution of adulterated drugs, announced the Food and Drug Administration (FDA) today.
The complaint, filed in the U.S. District Court for the Eastern District of Arkansas at the request of the FDA, alleges that defendants distribute adulterated drugs in interstate commerce. According to the complaint, defendants’ drugs are adulterated because they are prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health. The complaint also alleges that defendants’ drugs are adulterated because defendants fail to comply with current good manufacturing practice regulations.
Cantrell initiated voluntary recalls of drug products in 2016 and 2017. The 2016 recall, initiated due to lack of sterility assurance, involved 29 lots of unexpired sterile drug products. The 2017 recall, also due to a lack of sterility assurance, encompassed all lots of unexpired sterile drug products that Cantrell had compounded and distributed between Feb. 16, 2017, and July 19, 2017.
As alleged in the complaint, during the 2017 inspection, FDA documented evidence of insanitary conditions and significant deviations from current good manufacturing practice regulations. For example, as alleged in the complaint, FDA observed that the pharmacy’s own documentation revealed that Cantrell repeatedly recovered several types of microorganisms in the air and on surfaces used for sterile processing, demonstrating that products manufactured in those areas were prepared, packed, or held under insanitary conditions.
The presence of any of those organisms in an injectable product administered to a patient could cause serious adverse effects to the patient. The FDA found deviations from current good manufacturing practice regulations in the pharmacy’s sterile drug manufacturing operations. For example, the complaint alleges that the pharmacy failed to conduct adequate investigations of microbial contamination found in aseptic processing areas (on surfaces, in the air, and on personnel), as well as spore-forming bacteria detected in areas of the pharmacy used for drug compounding and on operator gloves.
Defendant: Cantrell Drug Company
Criminal Charges: Manufacturing and distribution of adulterated drugs
City and State: Little Rock, Arkansas
Exact Date: Filed in U.S. District Court for the Eastern District of Arkansas
Sentence or Outcome: Pending
Dollar Amounts: None
Key Facts
- State: Arkansas
- Category: Drug Trafficking
- Source: DOJ Press Release â†â€â€
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