The manufacturing issues continue to mount for India’s Cadila Healthcare. The drugmaker, which last year was hit with an FDA warning letter for two of its Indian plants, is now recalling several hundred thousand bottles of an antidepressant made at one of those plants.
According to the most recent FDA Enforcement Report, Cadila is recalling 26 lots of venlafaxine HCL ER capsules that accounted for 223,776 bottles, as well as another 9 lots for which it did not specify a bottle count.
The report says the drugs were manufactured in Ahmedabad and failed dissolution specs when retained samples were tested. Venlafaxine is an antidepressant used to treat major depressive disorder, anxiety and panic disorder.
In January, Cadila reported that it received a warning letter for a formulation facility, also in Moraiya, as well as its Zyfine API plant in Ahmedabad. Cadila insisted at the time that it takes quality seriously and will do what is necessary to meet FDA expectations. Among other issues, the FDA raised concerns about manufacturing of warfarin products, saying Cadila never got to the root cause of issues.
Several months later, a World Health Organization report indicated that Cadila had suspended manufacturing and recalled all the batches of Lyssavac-N (antirabies vaccine) manufactured after April 2015 inspections when it was found faking data about contamination issues at the facility.
- access the Enforcement Report here
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