Microbial contamination
Prescription Drugs
💊 Drugs • 12,141 recalls
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.
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Lupin Pharmaceuticals
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.