Class II · Moderate risk Terminated
Viatrexx-Connectissue
Reason Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
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Class III · Low risk Terminated
Levetiracetam Injection
Reason Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Class II · Moderate risk Terminated
Lyophilized Human Chorionic Gonadotropin 5
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Lyophilized Sermorelin w/ GHRP2 3 mg For injection
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Lyophilized Human Chorionic Gonadotropin 5
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Lyophilized Chorionic Gonadotropin 11
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
del Nido Cardioplegia Solution
Reason Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk Terminated
Amino Acid Injection 50 g/1000 mL
Reason Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
PF-Fentanyl Citrate
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
Leucovorin Calcium Injection
Reason Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk Terminated
Rifampin for Injection
Reason Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Class III · Low risk Terminated
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL
Reason Presence of Foreign Substance; Fiber particles.
Class II · Moderate risk Terminated
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection
Reason Lack of Assurance of Sterility: Bag has the potential to leak.
Class II · Moderate risk Terminated
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL…
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Motion Sickness Strips
Reason Subpotent Drug
Class III · Low risk Terminated
Wal-Dram 2
Reason Subpotent Drug
Class III · Low risk Terminated
Motion Sickness
Reason Subpotent Drug
Class III · Low risk Terminated
Zentrip
Reason Subpotent Drug
Class III · Low risk Terminated
Sankaijo BOTANICAL LAXATIVE
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.