On Jan 14th, 2014, Merck & Co. issued a voluntary recall of the cholesterol drug Liptruzet. What made this specific recall unique is that it was not focused on a single lot, or even several that had been distributed, but on all of the lots of the drug that were produced since the product’s launch in May of 2013.
The reason for this recall was a packaging defect. The product’s packing has outer pouches made of laminate foil which were found to potentially let moisture seep into the sealed packages and affect the tablets. Merck claimed that the defect is unlikely to decrease the drug’s effectiveness, nevertheless the drug is planned to be completely removed from market for the foreseeable future until the packaging defect can be corrected.
Recalls due to manufacturing defects are not uncommon. When a defect occurs after the product is already on the market, companies must act quickly to discover the cause of the defect and correct the manufacturing process. Chemical analysis of both the pharmaceutical product and its packaging can reveal the source of the defect, and any associated contamination or health risks. Since, in the case of Liptruzet, the packaging is thought to be defective and not the tablets themselves, much of the analysis will progress as a typical manufacturing failure analysis. Since it is a pharmaceutical product, however, documentation of manufacturing changes must be submitted to the FDA for review before the product can be cleared again to enter the market.
Considerations for Companies with Similar Product Defects
Avomeen’s scientists suggest that companies who experience similar pharmaceutical product defects should consider employing the following corrective measures:
• Initiate a product recall and inform the FDA
• Perform contamination testing on the drug product to determine safety and potency of the product still on the market
• Conduct a failure analysis on the product’s packaging to determine the cause of the defect
• Correct manufacturing issues and revise methodology
• Submit any post approval product changes to the FDA for consideration to restart manufacturing
Manufacturers and pharmaceutical companies use Avomeen to perform preventative testing before a defect occurs and to conduct failure analysis services when defects are found during production. These analytical services identify the source of product defects and correct the issue so production can continue.