Class II · Moderate risk
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Succinylcholine 200 mg/10 mL Syringe
Lack of Assurance of Sterility.
Class II · Moderate risk
Ropivacaine HCL
Lack of Assurance of Sterility.
Class II · Moderate risk
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Midazolam HCL 100 mg
Lack of Assurance of Sterility.
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 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 II · Moderate risk
Alprazolam Tablets
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class II · Moderate risk
methylPREDNIsolone ACETATE
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class II · Moderate risk
Medline Incision & Drainage Tray
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.