Class II · Moderate risk Terminated
Succinylcholine 200 mg/10 mL Syringe
Reason Lack of Assurance of Sterility.
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Class II · Moderate risk Terminated
Ropivacaine HCL
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Midazolam HCL 100 mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Hydromorphone HCl 10 mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
fentanyl citrate
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
fentaNYL citrate 1000 mcg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Terminated
A1 Slim
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk Terminated
Duloxetine Delayed-release Capsules USP
Reason Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk Terminated
Betadine Solution Swabstick Povidone-Iodine Solution USP
Reason Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Class III · Low risk Terminated
Famotidine tablets
Reason Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Class II · Moderate risk Terminated
Bisoprolol Fumarate tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class II · Moderate risk Terminated
Lorazepam Tablets
Reason Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Class II · Moderate risk Terminated
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk
Reason Microbial Contamination of Non-Sterile Products
Class II · Moderate risk Terminated
Glutamine
Reason CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class II · Moderate risk Terminated
Phenylephrine HCL 100 mcg per mL
Reason Superpotent Drug
Class III · Low risk Terminated
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.