As of August 2015, India’s generic pharma manufacturer Wockhardt Ltd. has ordered a total of 35 recalls of approximately 20 different drugs as part of a remediation plan in response to concerns arising from a 2013 inspection by the United States Food and Drug Administration (USFDA). Recalls include the antibiotics azithromycin and clarithromycin, three heart failure drugs lisinopril (generic PRINIVIL) and metoprolol (generic TOPROL) and captopril (generic CAPOTEN), three anti-seizure drugs phenytoin sodium (generic DILANTIN) and lamotrigine (generic LAMAICTIL) and zonisamide (generic ZONEGRAN) , the sleep disorder dug zolpidem (generic AMBIEN), blood pressure medications lisinopril (generic Prinivil) and amlodipine besylate (generic NORVASC), and the over-the-counter heartburn medication, famotidine (generic PEPCID). Current USFDA concerns include questions on the validity of drug testing, evidence that employees destroyed testing records and sanitation issues.
Initial USFDA Import Ban Due to Manufacturing Quality and Data Integrity Concerns
In April 2015, Wockhardt recalled certain batches of drugs manufactured at its two central India plants, Waluj and Chikalthana (Aurangabad, Maharashtra), as an “abundant precaution” to facilitate its remediation plan after a 2013 USFDA ban on imports due to manufacturing quality and data integrity concerns. According to Wockhardt, several batches produced at the two plants prior to the ban may still be circulating in the United States.
Wockhardt said, “As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as a part of remedial measure, all the remaining batches in the US market that were manufactured prior to the USFDA import alerts, even though there is no evidence of risk to patient safety from the products currently available in the US market.”
Concerns on Circulating Drugs Imported Prior to 2013 USFDA Ban
The two Aurangabad factories were re-inspected after the company completed several requested re-mediation measures. According to Wockhardt’s founder, chairman and group CEO, Habil Khorakiwala, the USFDA had no issues relating to data integrity and good manufacturing practices at the most recent inspection, however, the USFDA expressed concerns about drugs already circulating in the US market. “We have decided to recall 12-15 products in the market prior to import alerts,” Khorakiwala said. “These recalls do not include products that were allowed to be manufactured post alerts.”
Customer Complaints Not Addressed as a Part of Wockhardt Remediation Plan
In May 2015, Wockhardt recalled hypertension drugs captopril and antibiotic clarithromycin tablets. In June 2015, Wockhardt voluntarily recalled 85,000 containers of over-the-counter famotidine heartburn tablets based on a failure to adequately investigate customer complaints as a part of its remediation plan.
In recent months, the USFDA has raised concerns regarding manufacturing practices of India-based plants of several pharmaceutical entities, including Sun Pharmaceutical Industries Ltd. Sun Pharmaceutical said it is focusing on one plant at a time to restore the four Ranbaxy plants banned by the USFDA.