QuVa Pharma fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 recall — FDA D-0297-2025
Lack of Assurance of Sterility
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
Lack of Assurance of Sterility
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
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
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Super-Potent Drug: Out of specification potency results were obtained.
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
CGMP Deviations
Presence of foreign tablets/capsules
Chemical Contamination
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Presence of Particulate Matter
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20…
Chemical Contamination
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
CGMP Deviations
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Failed Impurities/Degradation Specifications
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
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