Class II · Moderate risk
Heparin Sodium 2
Lack of assurance of sterility: Bags have the potential to leak.
FDA Drug Recalls
97 recalls · Class II, newest first
Class II · Moderate risk
Glycopyrrolate Tablets
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
Quinapril and Hydrochlorothiazide Tablets
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk
Flunisolide Nasal Solution
Out of specification for related substances (impurities).
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II · Moderate risk
Triamcinolone Acetonide cream
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
QUAD-MIX 30/2/60/0.15 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 50/2.5/25 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/2/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/60 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/10 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Prop
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Dhea
Lack of Assurance of Sterility