India’s Lupin is recalling nearly 54,000 vials of an antibiotic made at its plant in Mandideep, India. It turns out that it is one of the facilities to receive citations during an inspection this year by the FDA.
According to the most recent FDA Enforcement Report, Lupin is recalling 53,902 vials of injected ceftriaxone because the drug was manufactured using active pharmaceutical ingredients whose intermediates failed specifications. The recall actually began in March but was just posted by the FDA after being deemed a Class III.
In March, Lupin reported in a filing with the Bombay Stock Exchange that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February. Lupin, who referred to the citations as "minor in nature," said one of the observations had to do with the use of a "non-conforming" intermediate.
Lupin last year also received a Form 483 with 9 observations for a plant in Goa, and the year before the FDA cited a facility in Indore with half a dozen.
Lupin, which claims to be one of the fastest-growing generics companies selling in the U.S., earlier this year completed a $900 million deal to buy New Jersey-based Gavis Pharmaceuticals. Lupin picked up in the deal a 45,000-square-foot manufacturing and R&D site and a 124,000-square-foot packaging and distribution operation in Somerset, NJ. It also got a portfolio of 120 marketed products and 62 ANDA filings.
- access the recalls here