FDA Cracks Down on KV Pharmaceutical, Maker of Defective Generic Drugs
KV Pharmaceutical, the company responsible for making generic heart drugs containing potentially deadly double doses of active ingredients, is facing tough new restrictions from the Food and Drug Administration.
The FDA just issued a permanent injunction against KV Pharmaceutical, preventing the company from making or selling drugs until the FDA finds that the company is in full compliance with federal drug-safety rules. The probation period will last for at least five years, the FDA said.
FDA Inspections Find ‘Significant Violations’
The company also is barred from manufacturing or distributing drugs until the company’s procedures and products are brought into compliance with the law, according to the FDA. Inspections of KV Pharmaceutical facilities between December 2008 and February 2009 found significant violations of federal laws regarding the production and shipping of prescription drugs, officials said.
KV Pharmaceutical is now barred from resuming the manufacturing and distribution of drugs until both an independent expert and FDA officials conduct inspections of company facilities and affirm that the facilities are in full compliance with the Federal Food, Drug, and Cosmetic Act, the FDA said.
FDA officials said based on the results of the recent inspections, they cannot ensure the “identity, strength, purity, and quality” of drugs made by KV Pharmaceutical.
Firm Penalties for Violations
If KV Pharmaceutical fails to comply with the requirements of the FDA injunction, federal officials may order the company to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions, officials said. The FDA said it will carefully monitor the company in an effort to ensure KV Pharmaceutical complies with the injunction.
Violations of the injunction will result in liquidated damages of $15,000 per day for each violation, up to $5 million per year, officials said.
Recall Announced in 2008
The new FDA rules for the company come just months after a recall of several KV Pharmaceutical drugs was ordered. On November 7, 2008, ETHEX Corp., a marketing subsidiary fully owned by KV Pharmaceutical, and the FDA announced that nine lots of generic drugs shipped before May 22, 2008 were being recalled due to concerns about the safety of the drugs.
FDA and company officials said the recalled lots of drugs for the treatment of irregular heartbeat and low blood pressure might contain oversized tablets containing potentially life-threatening doses of active ingredients.
The KV Pharmaceutical drugs recalled were propafenone HCl, isosorbide mononitrate, morphine sulfate, and dextroamphetamine sulfate. All drugs contained in the recall have been ordered destroyed, officials said.
Related posts:
- Defective Insulin Syringes Recalled GlucoPro Insulin Syringes made by Nipro Medical Corporation of Miami...
- FDA Cracks Down on Ready-to-Eat Sandwich Maker The Food and Drug Administration is trying to shut down...
- Bayer Warned About Quality of Drugs Made at German Plant The Food and Drug Administration has warned drug maker Bayer...
- Drug Maker Care-Tech Labs Agrees to Stop Producing Unapproved Antimicrobial Products Care-Tech Laboratories, a St. Louis-based drug manufacturer, has agreed to...
- SRAM Bicycle Chains and Chain Connector Links Recalled Due to Cracks About 24,000 10-Speed SRAM Bicycle Chains with PowerLock connector links...
