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:
Fosinopril Sodium and Hydrochlorothiazide
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Active Pharmaceutical Ingredients
Ganciclovir Sodium *
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