India's Lupin worked a license deal with Romark Laboratories a couple of years ago to handle sales in the U.S. of liquid diarrhea treatment Alina in the U.S., relying on its reps who handle sales of pediatric drugs. But some recent batches of the drug, often prescribed for children, are not up to specification, and so Romark is recalling them.
According to the most recent FDA Enforcement report, Romark is voluntarily recalling 5 lots, comprising nearly 33,000 bottles of Alina, because they didn't pass the stability specification for viscosity at the 12-month stage.
Alinia oral suspension is approved for treating of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 months of age and older. It is the only product approved in the United States for treating diarrhea caused by Giardia lamblia in children under 4 years of age.
The recalls comes as the Tampa-based Romark is in the process of expanding its manufacturing operations to Puerto Rico where it will manufacture Alina, as well as an influenza product it has under development that it hopes to launch in 2016. The $110 million facility will also house some research and development operations and is expected to have up to 200 employees when it ramps up over the next three years.
- here's the recall notice