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FDA Seizes Dangerous Prescription Drugs From Caraco Pharmaceutical Laboratories


Posted on Jun 26, 2009

Today the Food & Drug Administration seized 33 generic drugs and ingredients from the Caraco Pharmaceutical Laboratories worth an estimated $20 million. The potentially defective drugs were seized after the company's continued failure to meet drug manufacturing regulations and requirements. However, the FDA also told consumers not to interrupt taking any Caraco drug they are on until the FDA notifies the public of any risk discovered after they analyze the drugs.

"The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."

Earlier this year, Caraco received two separate warnings from the FDA regarding their manufacturing practices. When the FDA returned to check on improvements, they still found 18 different objectionable conditions at the factory and decided to take action. Two of the objectionable conditions included the improper control of their raw ingredients and too much variation in their tablets.

Since January, Caraco has voluntarily recalled drugs the FDA deemed defective, including oversized pills with possible errors in contents due to manufacturing defects. The company makes a number of different generic drugs that treat mood disorders and pain.

Drugs Manufactured by Caraco Include:


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

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