Presence of foreign substance: Presence of stainless steel particulates in tablets.
MERCK SHARP & DOHME
Presence of Particulate Matter: Identified as Glass Particles
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.