FDA Halts Importation of Drugs Manufactured Offshore By Ranbaxy

Drugs From 2 Plants Affected

The FDA has issued an alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process.

The Import Alert issued by the FDA on Sept 16, allows for US officials to detain at any US border, any active pharmaceutical ingredients, both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The FDA Import Alert covers more than 30 different generic drug products (see affected drugs below) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.

The affected drugs are: acyclovir, cefprozil, cefuroxime axetil, cephalexin, ciprofloxacin HCl, clarithromycin, fenofibrate, fluconazole, fosinopril sodium, fosinopril sodium and hydrochlorothiazide, gabapentin, glimepiride, isotrentinoin, lamivudine, loratadine OTC, metformin HCl, nefazodone HCl, nitrofurantoin, nitrofurantoin and macrocystalline, ofloxacin, pravastatin sodium, ranitidine, simvastatin, terazozin HCl, valacyclovir HCl, and zidovudine (PEPFAR).

This FDA announcement does not impact products from Ranbaxy's other plants which are not affected by yesterday's actions, and that are already in the US.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

SEPT-17-08: FDA Issues an Import Alert for Drugs from Two Ranbaxy Plants in India [CPSC: FDA HALTS IMPORTED DRUGS FROM INDIA]

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Published on Sep-17-08