Class II · Moderate risk Ongoing
Ergocalciferol - Vitamin D Supplement - 10 mcg
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
FDA Drug Recalls
2,661 recalls, newest first
Class I · High risk Ongoing
BD ChloraPrep Clear 1mL Applicators
Reason Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class II · Moderate risk Ongoing
Iodo Blanco Iodides
Reason Defective Container: broken or leaking bottles.
Class II · Moderate risk Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical
Reason Chemical Contamination
Class II · Moderate risk Ongoing
Kids by babyganics SPF 50 totally tropical
Reason Chemical Contamination
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason 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 mEq is printed on the labeling affixed to the product flexible container.
Class II · Moderate risk Ongoing
Nelarabine Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Nelarabine Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
ViaMed Alcohol Prep Pads
Reason Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Class II · Moderate risk Ongoing
Voriconazole Container Description: voriconazole The product…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Chlorambucil Container Description: The product packed in double…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Finasteride NDC# 82187-1003-1 Container Description: The product…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Alprostadil Container Description: Amber color bottle
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Bimatoprost NDC# 82187-1001-1 Container description: The…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Silodosin Capsules
Reason Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class II · Moderate risk Ongoing
Ciprofloxacin Ophth Solution
Reason 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
Class I · High risk Ongoing
Fentanyl Transdermal System CII
Reason Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class II · Moderate risk Ongoing
Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.