Class II · Moderate risk Ongoing
Elitek
Reason Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Just Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
Always Be Clean Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk Terminated
UltraCruz Hand Sanitizing Gel Antimicrobial
Reason Subpotent drug
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP
Reason Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk Terminated
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ketamine 50 mg Infusion
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Trimix
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Command Brands GelAnti Bac Instant Hand Sanitizer
Reason CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk Terminated
Day & Night Pack Ear Itch MD Anti-Itch Spray
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Itch MD Anti-Itch Spray
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops with 4% Lidocaine
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops For Kids
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason Subpotent drug: Out of specification for assay at the 15-month test interval.
Class II · Moderate risk Terminated
Leiper's Fork Distillery
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Class II · Moderate risk Terminated
Jaloma Antiseptic Hand Sanitizer
Reason cGMP deviations