Class II · Moderate risk Terminated
Midazolam Injection
Reason Failed Impurities/Degradation Specifications
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Gentell Hydrogel Wound Dressing REGULAR
Reason CGMP Deviations
Class II · Moderate risk Terminated
Gentell Hydrogel Ag Saturated Gauze
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
AMGEN Kyprolis
Reason Lack of Assurance of Sterility: Potential cracks in glass vials
Class II · Moderate risk Terminated
Torsemide Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Torsemide Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Rabeprazole Sodium Delayed Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
10% Premasol sulfite-free
Reason Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk Terminated
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
Reason CGMP Deviations
Class II · Moderate risk Terminated
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
Reason CGMP Deviations
Class II · Moderate risk Terminated
CVS Health Homeopathic Infants Teething Tablets 135 count bottle…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Rocuronium Bromide 50 mg/5 mL Injection Solution
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Lidocaine HCl 1%
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Heparin Sodium 5
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.