Both products came out of the company's plant in Baddi. In 2017, the FDA issued a Form 483 for the facility, pointing out it had received more than 20 complaints about a cream that buyers said was watery. Warehouse records showed the drug had been stored for more than 30 hours at temperatures that ran as high as 112˚F, and the company didn't investigate whether that was the root cause of the texture issue. Glenmark has had issues at other plants. The FDA issued a CRL in June for its New Drug Application for Ryaltris, a nasal spray to treat seasonal allergic rhinitis and Glenmark's leading respiratory pipeline candidate. It said the CRL cites deficiencies in the Drug Master File relating to one of the active pharmaceutical ingredients as well as in the manufacturing facilities.