Jubilant HollisterStier Recalls Misbranded Allergenic Extract

Jubilant HollisterStier based Spokane, Washington, USA offering sterile manufacturing services through Commercial liquid and lyophilized products in vials and ampoules, as well as ophthalmic and otic solutions, ointments and suspensions in bottles and tubes.
Its Contract Manufacturing & Services is an integrated contract manufacturer, able to manufacture sterile injectable, solid and semi forms. Its facilities across North America (Spokane, Washington, in USA and Montreal, Quebec in Canada and India) provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries.
Jubilant HollisterStier is approved across global regulated markets including FDA (both CDER and CBER), Europe, Japan, Brazil and Canada.

The company issued a Voluntary Recall of Pullularia pullulans. Pullularia is a mildew type of mould that can live in water, on wood, metal and in rotting vegetation. This yeast-like fungus is commonly found on caulk or damp window frames in bathrooms.


The recall was for 1 Lot; 44 vials as the company distributed a misbranded allergenic extract. Since the recall was just for a single lot, the recall has been closed immediately as the company was able to locate the product and take the necessary action within 30 days (Recall Initiation Date was 19-Oct and the Termination Date was 17-Nov). The recall was a Class III initiated in the United States alone.
This is the first recall for the company in 2016 while its previous 10 recalls were back in 2013. The company reported a PAT of US $ 2.1 million against a Revenue of US $ 102.4 million for the year ended March, 2016