Class II · Moderate risk
Midazolam HCL 100 mg
Lack of Assurance of Sterility.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydromorphone HCl 10 mg
Lack of Assurance of Sterility.
Class II · Moderate risk
fentanyl citrate
Lack of Assurance of Sterility.
Class II · Moderate risk
fentaNYL citrate 1000 mcg
Lack of Assurance of Sterility.
Class II · Moderate risk
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride
Lack of Assurance of Sterility.
Class II · Moderate risk
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Lack of Assurance of Sterility.
Class II · Moderate risk
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
A1 Slim
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
Duloxetine Delayed-release Capsules USP
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
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
Famotidine tablets
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
Bisoprolol Fumarate tablets
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class II · Moderate risk
Lorazepam Tablets
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Class II · Moderate risk
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Glutamine
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class II · Moderate risk
Phenylephrine HCL 100 mcg per mL
Superpotent Drug
Class III · Low risk
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Ampicillin for Injection
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class III · Low risk
Carbamazepine Oral Suspension USP
Subpotent Drug: low out of specification results.