Class II · Moderate risk
PHENYLephrine in 0.9% sodium chloride
Lack of assurance of sterility:
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
lidocaine 2%
Lack of assurance of sterility:
Class II · Moderate risk
ePHEDrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
ketamine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
fentaNYL in 0.9% sodium chloride
Lack of assurance of sterility:
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class I · High risk
TheraBreath for Kids! Oral Rinse
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
octiq Lubricating Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
MAJOR LubriFresh P.M. Nighttime Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes
Lack of Assurance of Sterility