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
14,806 recalls, newest first
Class I · High risk
Forever Beautiful BEE POLLEN
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class I · High risk
Forever Beautiful INFINITY
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class II · Moderate risk
Meropenem I.V. 1 g is supplied in 30 mL injection vials
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
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 II · Moderate risk
Mercaptopurine Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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 II · Moderate risk
Gabapentin Capsules
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Class II · Moderate risk
Obagi Nu-Derm Clear
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
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 II · Moderate risk
Cyproheptadine HCl Syrup
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Class II · Moderate risk
Tri-mix #4
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Class II · Moderate risk
Lidocaine 4% Syr
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Class II · Moderate risk
Epinephrine 1:1000
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Class II · Moderate risk
Sterile Water for Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
Normosol-R Multiple Electrolytes Injection Type 1
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.