Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
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
Fentanyl Citrate
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Stability data does not support expiry.
Class II · Moderate risk
Ondansetron 2 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Midazolam
Subpotent drug.
Class II · Moderate risk
Succinylcholine 20 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Rocuronium 10 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Phenylephrine
Stability data does not support expiry.
Class II · Moderate risk
Epinephrine
Subpotent drug.
Class II · Moderate risk
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Cevimeline Hydrochloride Capsules
Failed Stability Specifications: product may not meet specification limit for assay test.
Class II · Moderate risk
Bromfenac Ophthalmic Solution
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class II · Moderate risk
Mupirocin Calcium Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban (mupirocin calcium)
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Midazolam HCl Syrup
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class II · Moderate risk
DuraPrep Surgical Solution Iodine Povacrylex
Chemical contamination: Product may be contaminated with a toxic compound.
Class II · Moderate risk
Rivastigmine Tartrate Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Hydrochlorothiazide Tablet USP 25 mg
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Class II · Moderate risk
Lisinopril Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.