Multiple safety violations revealed in U.S. prescription manufacturing plants
The Food and Drug Administration has been busy this past month cracking down on U.S. and Canadian drug manufacturers for violations of proper production standards and cleanliness. We blogged last week on FDA inspections at Mylan’s Puerto Rico prescription plant, and this week the FDA added another company to its growing list of prescription safety violators.
U.S. FDA finds safety violations at Novartis plants in US and Canada.
This summer, the FDA inspected Novartis generic drug manufacturing plants in Broomfield, Colorado, Wilson, North Carolina, and in Quebec. The FDA found violations ranging from improper sterility procedures to not ensuring quality and proper make-up of drugs to the required standard, and poor cleanliness at plants, even after cleaning was signed off on by management.
Those weren’t the only violations. According to the FDA, crystals were found to be allowed into injectable drugs, composition of drugs was improper (either too much or not enough of either the active medicinal ingredients or the wrong amount of binders in pills).
This is a sad and scary state for American and Canadian users of generic drugs made by Novartis. If you use a drug made by Novartis, look very carefully at the drug - if you see cloudiness or crystallization in your injectable, immediately return them to the pharmacy and call your doctor. For safety’s sake, it may be a good idea to call your doctor before using any Novartis drug, to see if there is another, alternative medication for you.
The FDA did not release the names of the generic drugs made at these three plants.
Check your prescription labels - by law the label must inform you who the maker of the drug is; if you become ill from taking one of these drugs, go to the nearest emergency room with all your prescription medicines and over the counter medicines. When you get out of the hospital, it is important to contact a medication error attorney immediately.
Order our free pharmacy error book to learn how to take action if you or someone you love was harmed by a medication error.