Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
LIPO B STERILE INJECTION 10 mL
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Class II · Moderate risk
Blephamide
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
FML (fluorometholone ophthalmic ointment)
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh P.M.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh Lacri-Lube
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Labeling: Wrong Bar Code
Class II · Moderate risk
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe
Subpotent Drug
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride Injection
Subpotent Drug
Class II · Moderate risk
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection
Subpotent Drug
Class II · Moderate risk
HEPARIN Sodium in 0.45% Sodium Chloride
Stability Data Does Not Support Expiry
Class II · Moderate risk
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE
Stability Data Does Not Support Expiry
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class II · Moderate risk
Ketamine Hydrochloride Injection
Defective Container: There were customer complaints of cracked and leaking glass vials.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride
Stability data does not support expiry.
Class II · Moderate risk
Lidocaine HCI
Stability data does not support expiry.
Class II · Moderate risk
Midazolam 1 mg/mL in 0.9% Sodium Chloride
Stability data does not support expiry.