Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
PAPAVERINE HYDROCHLORIDE Injection
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
TETRACAINE 1% Tetracaine HCI Injection
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
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class II · Moderate risk
Rock Town - Distillery - Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug