Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Class II · Moderate risk
Nitroglycerin Transdermal System 0.4 mg/hr
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
Nitroglycerin Transdermal System 0.2 mg/hr
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
Capecitabine Tablets
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Hydroxyprogesterone Caproate 250
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phentolamine 5 mg/mL in Normal Saline
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 500 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/20 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/2/20 Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 20/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 6/0.33/3.33 Injection Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 17/0.6/5.7 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 20 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.