💊 Drugs • 12,141 recalls
Guardian Drug Co.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
SUN PHARMACEUTICAL INDUSTRIES
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Presence of foreign substance: small metallic particles in chewable tablets.
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
Presence of foreign substance: small metallic particles in chewable tablets.
SUN PHARMACEUTICAL INDUSTRIES
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Presence of foreign substance: small metallic particles in chewable tablets.