Drug Repackager Slammed With Consent Decree for Mislabeling
September 20th, 2013 // 12:45 am @ jmpickett
Back in June, FDA sued Shamrock Medical Solutions Group, which is a prescription drug repackager, for not following proper FDA regulatory laws regarding its continuing to distribute contaminated and misbranded medical products. Now, FDA has gotten a consent decree and Shamrock has had to cease its operations. The decree also named for executives for the company.
This move by FDA is the latest where the agency is coming down hard on drug companies that are damaging the credibility of the drug supply chain. For the last several months, FDA has been focusing on pharmacy compounding companies. Last week, FDA issued an import alert for Ranbaxy Labs due to several cGMP problems.
Shamrock is a repackager of drugs into certain dosages and then distributes them to various pharmacies in hospitals around the US. Over the last 36 months, FDA has done several audits, and it issued two warning letters to the company.
For example, there was a drug batch that was not labeled right – as morphine – but was really oxycodone. The latter is much more potent. FDA also noted that the company was distributing drugs with dosage strengths that were incorrect, and it did not ID a drug properly as extended release. In April, the agency stated in a letter given to healthcare providers that Shamrock drugs were being mislabeled.
