Class II · Moderate risk Terminated
Thiamine Hydrochloride 200 mg/2mL
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablet
Reason Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Terminated
Oxcarbazepine Tablets 600mg
Reason Presence of foreign substance
Class II · Moderate risk Terminated
FentaNYL Citrate 2.5 mg/50 mL
Reason Underfilled units.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container…
Reason Lack of sterility assurance: Bags have the potential to leak.
Class II · Moderate risk Terminated
Desmopressin Acetate Tablets 0.2mg
Reason Subpotent Drug
Class II · Moderate risk Terminated
Sensorcaine-MPF
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Terminated
Sensorcaine
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Terminated
Sensorcaine
Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
PF-Neostigmine Methylsulfate Injection
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk Terminated
Phenoxybenzamine Hydrochloride Capsules
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum
Reason CGMP deviations
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.