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News
Natco Plant in India Not Meeting Standards
Another Indian pharmaceutical company has had plants cited by the FDA for not maintaining manufacturing standards. Natco reported it received Form 483s for its pharmaceutical formulations facility at Kothur, near Hyderabad, as well as an API plant at Manali, near Chennai, which it had to close in December because of flooding in the area.
http://corporates.bseindia.com/xml-data/corpfiling/AttachLive/
BE3A322C_E35D_4653_AC85_B7C2311E08EB_174624.pdf
Anuh Pharma Plant Criticized
Indian Anuh plant sourced ingredient from a China company EU banned two years ago. India's Anuh Pharma has informed authorities in India that its Boisar plant had been banned from shipping products to Europe after the European Medicines Agency (EMA) stopped its manufacturing certificate. In a report from a February visit, the EMA said French inspectors documented two dozen deficiencies at the plant and found overall quality so lacking that it recommended recalling from Europe all of the antibiotic APIs the plant manufactures because their original sources were unknown.
http://www.fiercepharmamanufacturing.com/story/anuh-pharma-plant-savaged-ema-report/2016-03-31
Dr. Reddy's Recalling Injectable
India's Dr. Reddy's Laboratories had to recently recall nearly 25,000 bottles of a dialysis drug after complaints of container leaks. Now, it is recalling 3,342 vials of zoledronic acid injection over questions of sterility after some were found to have defective seals. The drug product was produced by Gland Pharma. This recall comes at a bad time for Dr. Reddy's, which is already dealing with issues at three manufacturing plants the FDA cited last year.
http://www.fiercepharmamanufacturing.com/story/dr-reddys-recalling-injected-drug-manufactured-gland-pharma/2016-03-31
Records of 80,000 Novartis "Sham" Events for Doctors Being Investigated
Novartis AG is being required to provide records of about 80,000 "sham" events in which the government says doctors were wined and dined so they would prescribe the company's cardiovascular drugs to their patients. Novartis and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to healthcare providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed. Last year, Novartis agreed to pay $390 million to settle a lawsuit in which the U.S. government claimed the Swiss company paid kickbacks to pharmacies to boost sales of some of its prescription drugs. The company neither admitted nor denied liability.
http://www.bloomberg.com/news/articles/2016-03-26/u-s-seeks-records-of-80-000-novartis-sham-events-for-doctors
Reliable Drug Pharmacy Recalling Compounded Products
Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. The products were distributed to patients and veterinarians within California as well as a few products that were shipped to Hawaii, New Mexico, and Michigan. The recall was issued after a series of onsite inspections by the FDA. The recall impacts all compounded products distributed between 09/24/2015 and 03/24/2016.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman
MedicalProducts/ucm492677.htm
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