FDA Bans Import Of 30 Popular Generic Drugs

The FDA has banned the import of 30 different generic drugs made by Ranbaxy due to unresolved ongoing concerns about quality controls in the manufacturing process. Some of them are popular, like a generic for Zocor. The complete list inside. If you’re taking any of the affected drugs, keep taking them. The FDA found no evidence to suggest any consumers are at risk. If you have concerns, consult your doctor.

Here’s the drugs affected by the embargo:

Acyclovir
Cefprozil
Cefuroxime Axetil
Cephalexin
Ciprofloxacin HCl
Clarithromycin
Fenofibrate
Fluconazole
Fosinopril Sodium
Fosinopril Sodium and Hydrochlorothiazide
Gabapentin
Ganciclovir Sodium
Glimepiride
Isotretinoin
Lamivudine
Loratadine (OTC)
Metformin HCl
Nefazodone HCl
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Ofloxacin
Pravastatin Sodium
Ranitidine
Simvastatin
Terazosin HCl
Valacyclovir HCl
Zidovudine (PEPFAR)

Active Pharmaceutical Ingredients
Clarithromycin
Valacyclovir HCl
Pravastatin Sodium
Acyclovir
Ciprofloxacin HCl
Ganciclovir Sodium *
Gabapentin

These are the citations from the warning letters the FDA sent to Ranbaxy that were not resolved and prompted the import ban:

* The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
* Inadequate batch production and control records;
* Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
* Inadequate aseptic (sterile) processing operations.
* The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP (current Good Manufacturing Practice);
* Inaccurate written records of the cleaning and use of major equipment;
* Incomplete batch production and control records; and,
* Inadequate procedures for the review and approval of production and control records for drug products

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India [FDA] (Thanks to Chris!)

(Photo: Schodts)