All recalls8,517 total
cGMP deviations and lack of assurance of sterility.
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Undeclared allergen ingredient (milk)
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
CGMP Deviations; potential temperature excursions due to transit delays
CGMP Deviations; potential temperature excursions due to transit delays
CGMP Deviations; potential temperature excursions due to transit delays
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.
Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.
Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.
Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Product contains undeclared wheat.
Salsa products are recalled due to potential contamination with wood particles.
Salsa products are recalled due to potential contamination with wood particles.
Presence of Particulate Matter
Product is contaminated with Listeria monocytogenes.
Product contains elevated levels of lead (0.0649 mg/kg)
Potential for contamination with salmonella.
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Lack of Assurance of Sterility
Firm's salsa product was potentially manufactured with a recalled ingredient (Fresh Cilantro containing foreign objects "wood pieces")
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Glass fragments found in finished product.