Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/mL
Reason Stability data does not support expiry.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Morphine Sulfate
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Fentanyl Citrate
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Midazolam
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Ondansetron 2 mg/mL
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Midazolam
Reason Subpotent drug.
Class II · Moderate risk Terminated
Succinylcholine 20 mg/mL
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Rocuronium 10 mg/mL
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Phenylephrine
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Epinephrine
Reason Subpotent drug.
Class II · Moderate risk Terminated
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
Cevimeline Hydrochloride Capsules
Reason Failed Stability Specifications: product may not meet specification limit for assay test.
Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution
Reason Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk Terminated
Vytorin
Reason 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 Terminated
Mupirocin Calcium Cream
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk Terminated
Bactroban Cream
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk Terminated
Bactroban Ointment
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk Terminated
Bactroban
Reason Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk Terminated
Midazolam HCl Syrup
Reason Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class II · Moderate risk Terminated
DuraPrep Surgical Solution Iodine Povacrylex
Reason Chemical contamination: Product may be contaminated with a toxic compound.
Class II · Moderate risk Terminated
Rivastigmine Tartrate Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Hydrochlorothiazide Tablet USP 25 mg
Reason Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Class II · Moderate risk Terminated
Lisinopril Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.