Microbial contamination
Drugs Recalls
Prescription and over-the-counter medications
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
Jubilant Cadista Pharmaceuticals
Failed Dissolution Specifications; 9-monthstability timepoint
Cross Contamination: Presence of IPA in finished product.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.