Class II · Moderate risk Ongoing
suntegrity
Reason CGMP Deviations
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Class I · High risk Ongoing
suntegrity
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Class II · Moderate risk Ongoing
Dexamethasone Sodium Phosphate injection USP
Reason Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk Ongoing
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Reason Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk Ongoing
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class III · Low risk Ongoing
Eptifibatide injection 20mg/10mL
Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Class II · Moderate risk Ongoing
Extra Strength Acetaminophen 500 MG Tablets
Reason Discoloration: Brownish tablets
Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Ongoing
Buprenorphine Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk Terminated
Cathflo activase
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class III · Low risk Terminated
Tivicay PD
Reason Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing
Pregabalin Capsules 50mg
Reason Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class II · Moderate risk Terminated
Eylea
Reason Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Klarity-C
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin- Ketorolac
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
niCARdipine Hydrochloride Injection
Reason Lack of Assurance of Sterility.