Class II · Moderate risk
Clonidine Hydrochloride Tablets
cGMP Deviations
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 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
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
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 III · Low risk
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…
Subpotent Drug: menthol and methyl salicylate below specification
Class III · Low risk
Cvs Sugar Free Black Cherry Cough Drops
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
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 I · High risk
Zero Xtreme High Performance Fat Burner capsules
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
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 III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class III · Low risk
Metoclopramide Oral Solution
Defective Container: Lids on unit dose cups are not fully qualified.
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.