Class III · Low risk
Sterile powder Vancomycin Hydrochloride for Injection
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Scrub Care Chlorhexidine Gluconate Solution
Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Class III · Low risk
Carbamazepine Tablets USP
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
Candesartan Cilexetil Tablets
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Class III · Low risk
TORISEL Kit
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class III · Low risk
candesartan cilexetil
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Class III · Low risk
Locoid (hydrocortisone butyrate 0.1%)
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Hydrocortisone Butyrate Cream 0.1%
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Amlodipine Besylate Tablets
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class III · Low risk
BENZONATATE Capsules
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Class III · Low risk
MethylPREDNISolone TABLETS
Subpotent; 6 month stability time point
Class III · Low risk
Warfarin Sodium Tablets
Failed Content Uniformity Specifications.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Class III · Low risk
CHIROTHIN Dietary Supplement
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Class III · Low risk
Nicotine Polacrilex Lozenge
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class III · Low risk
Depo-Medrol
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0