WASHINGTON,- Federal marshals dispatched by the FDA have stopped all shipments from three generic drug manufacturing plants in Michigan operated by Caraco Pharmaceutical Laboratories.
The action affects 33 different drugs. It was taken after the company repeatedly failed to correct defects in its manufacturing processes, FDA officials said, despite a warning letter last October and several recalls this year.
Deborah Autor, director of the compliance office at FDA's Center for Drug Evaluation and Research, said the agency's most recent inspection, in May, revealed "serious deficiencies" in the quality control at the plants.
Earlier this year, Caraco had initiated recalls for oversize tablets and formulation errors.
The affected drugs include generic versions of many widely prescribed medications, including the antidiabetic agents glipizide and metformin; high blood pressure meds atenolol, carvedilol, and hydrochlorothiazide; and the psychotropic medications clozapine, clonazepam, and paroxetine.
The company is prohibited from shipping products until the FDA certifies that it is meeting its so-called cGMP quality control standards.
Autor emphasized that patients currently taking drugs produced by Caraco should not stop them. No problems with drugs shipped recently from the plants have come to light, she said.
"All the products we knew to be defective have been recalled [previously]," she said.
She added that the agency would act quickly if it learns of other defects.
In the meantime, the FDA will work with Caraco management to resolve the manufacturing problems.
"Our goal is to get Caraco up and running safely," Autor said. She was unable to say how long that may take.
For one product -- choline magnesium trisalicylate, an oral painkiller -- the action will create a shortage because Caraco has been the sole supplier.
Autor said physicians should look for alternative medications for their patients now on this drug.
Here is the full list of Caraco drugs affected by the seizure:
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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