Class II · Moderate risk Terminated
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags
Reason Lack of Assurance of Sterility.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 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 II · Moderate risk Terminated
Alprazolam Tablets
Reason Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class II · Moderate risk Terminated
methylPREDNIsolone ACETATE
Reason Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class II · Moderate risk Terminated
Medline Incision & Drainage Tray
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Suture Removal Tray
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Suture Removal Tray
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Abdominal Surgery II Pack-LF
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Incision Drainage Tray
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Skin Stapler RMVR
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Professional Hospital Supply Suture Removal Kit
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Class II · Moderate risk Terminated
Medline Suture Removal Pack Latex Safe
Reason Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.