Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride
Reason Lack of assurance of sterility:
FDA Drug Recalls
17,898 recalls, newest first
Class I · High risk Terminated
Betaxolol Tablets
Reason Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class III · Low risk Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Reason Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk Terminated
Eligard
Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk Ongoing
TheraBreath for Kids! Oral Rinse
Reason Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class III · Low risk Terminated
Cequa
Reason Subpotent: Out of Specification result observed for low assay
Class III · Low risk Terminated
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Reason Incorrect/Undeclared Excipients.
Class II · Moderate risk Terminated
Pantoprazole Sodium for Injection 40mg per vial
Reason Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk Ongoing
octiq Lubricating Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
MAJOR LubriFresh P.M. Nighttime Ointment
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility