Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
FDA Drug Recalls
360 recalls · Class II, newest first
Class II · Moderate risk
Alcolado Relampago
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Yager's Liniment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Blis-To-Sol Liquid
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Cromolyn Sodium Oral Solution
CGMP deviation: product released prior to supplier approval.
Class II · Moderate risk
Pain Reliever
Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Class II · Moderate risk
Ascorbic Acid Preserved Injection Solution
Mislabeling: preservative free product labeled as preserved.
Class II · Moderate risk
Calcitonin Salmon
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Brimonidine Tartrate Ophthalmic Solution 0.15%
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Class II · Moderate risk
Heparin Sodium 2
Lack of assurance of sterility: Bags have the potential to leak.
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.