Class II · Moderate risk Terminated
Clobetasol Propionate Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Clobetasol Propionate Lotion
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Clobetasol Propionate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Clobetasol Propionate Cream USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Betamethasone Dipropionate Lotion USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
PHENOBARBITAL Sodium Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PHENOBARBITAL Sodium Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
PAPAVERINE HYDROCHLORIDE Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
TETRACAINE 1% Tetracaine HCI Injection
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to…
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Sucralfate Oral Suspension
Reason Labeling: Label Mix-Up
Class II · Moderate risk Terminated
Rock Town - Distillery - Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class II · Moderate risk Terminated
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Reason Super Potent and Failed Reconstitution Time
Class II · Moderate risk Terminated
NAD+ Nicotinamide Adenine Dinucleotide
Reason Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk Terminated
Sermorelin Acetate Lyophilized powder for reconstitution
Reason Sub Potent
Class II · Moderate risk Ongoing
Glutathione 200mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Vitamin D3 50
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Vitamin B-Complex Preservative Free
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Vitamin B-Complex
Reason Lack of Assurance of Sterility