Class II · Moderate risk
Rabeprazole Sodium Delayed Release Tablets
Failed Dissolution Specifications
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
10% Premasol sulfite-free
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
Fluconazole Injection
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Class II · Moderate risk
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz
CGMP Deviations
Class II · Moderate risk
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz.
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Ropivacaine HCl 0.25% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Rocuronium Bromide 50 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Lidocaine HCl 1%
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium 5
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Heparin Sodium
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Glycopyrrolate 1 mg/5 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 2
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Fentanyl Citrate 1
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.