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Questions and Answers: Seizure of Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.

Questions and Answers about Caraco Drugs

What is FDA announcing today? 
FDA is announcing that U.S. Marshals, at the request of FDA, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Detroit, Farmington Hills, and Wixom, Michigan facilities. The seizure also includes ingredients held at these same facilities. This action follows the company's continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements.

Why is the FDA taking this action?
Today's action is a preventative measure because Caraco's manufacturing processes do not meet FDA's quality standards. FDA inspections of Caraco have documented serious violations of cGMP regulations. The most recent inspection which ended in May 2009 revealed serious deficiencies in the control of the company's manufacturing practices. Since January 2009, Caraco has recalled a number of products due to manufacturing defects, including oversized tablets.

Today's action is intended to minimize the likelihood that a product could fail to meet quality standards and specifications, resulting in an unsafe or ineffective drug. Seizures often lead to court orders that require companies to take steps to correct cGMP violations in their manufacturing processes. These steps may include hiring outside experts, writing new procedures, and conducting extensive training of their employees.

What products are affected by today's announcement?
Caraco manufactures 33 drugs in multiple strengths that may be affected by today's action. Below is a list of drugs manufactured by Caraco. FDA is seizing all Caraco-manufactured drugs that are on the Caraco premises. This includes many or all of the listed drugs. After a seizure, companies often temporarily cease all manufacturing.

Drugs Manufactured by Caraco

Allopurinol Tablets
Amlodipine Tablets
Atenolol Tablets
Baclofen Tablets
Carvedilol Tablets
Cetirizine Tablets
Cetirizine IR Tablets
Choline Magnesium Trisalicylate Tablets
Citalopram HBR Tablets
Clonazepam Tablets
Clozapine Tablets
Digoxin Tablets
Flurbiprofen Tablets
Fluvoxamine Maleate Tablets
Glipizide Tablets
Glipizide/Metformin Tablets
Hydrochlorothiazide Tablets
Meloxicam Tablets
Meperidine HCl C-II Tablets
Metformin Tablets
Methimazole Tablets
Metoprolol Tartrate Tablets
Midrin Capsules
Mirtazapine Tablets
Oxaprozin Tablets
Paromomycin Sulfate, USP Capsules
Paroxetine Tablets
Phentermine HCl Tablets
Ticlopidine HCl Tablets
Tizanidine HCl Tablets
Tramadol HCl Tablets
Tramadol HCl/Acetaminophen Tablets
Zolpidem Tartrate Tablets

Will there be a drug shortage if products from these plants are no longer available in the United States?
There may be a shortage of choline magnesium trisalicylate oral tablets. FDA suggests that health care providers consider alternative treatments. FDA does not anticipate that the seizure of Caraco's drugs will cause a shortage for consumers of any other drug because other manufacturers continue to produce the same drugs that Caraco makes. However, there could be “spot” or local shortages until other manufacturers' products are shipped to pharmacies. In such cases, FDA suggests that health care providers consider alternative treatments for their patients. If consumers have difficulty filling prescriptions for any products made by Caraco, or if health care providers are not able to locate alternatives, please contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.

What does FDA advise consumers to do if they are taking medicines from Caraco?
The FDA advises consumers taking medicines from Caraco not to interrupt their drug therapy. If FDA identifies Caraco drugs on the market that pose risks to patient safety, the Agency will take additional regulatory action and immediately notify the public. Maintaining drug quality standards remains a top priority for FDA.

Should I see my health care provider if I want my prescription refilled with a drug from a manufacturer other than Caraco?
FDA advises any consumer who is concerned about their drugs to discuss those concerns with their health care providers.

Where can I find additional information on the current Good Manufacturing Practices (cGMPs) and how these practices contribute to drug quality?
FDA has recently posted additional information on cGMP. That information can be found at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm. This post discusses the role and importance of cGMP in drug manufacturing, as well as describes what actions FDA takes when a company is not in compliance with cGMP.

 

FDA Press Release