Class I - Dangerous
Presence of Particulate Matter: Presence of glass particle.
Gilead Sciences
Class I - Dangerous
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Defective Container; leaking around the cap
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).