Class II · Moderate risk
GREENSTONE BRAND fluconazole for Oral Suspension
Defective Container: Tamper evident ring failures discovered on some bottles.
FDA Drug Recalls
1,055 recalls · Class II, newest first
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Dextroamphetamine Saccharate
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Ethambutol Hydrochloride Tablets
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Class II · Moderate risk
Heparin Sodium Injection
Subpotent; 18 month time point
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Cooling Eye Drops
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Dry Eye
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Class II · Moderate risk
Guaifenesin USP
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Class II · Moderate risk
Therametics Complexion Repair Topical Rehydrating Emulsion in 50…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Calm and Correct Cream 2 oz. containers in the…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Post Procedure Cream 1 oz. containers in the…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Calm and Correct Serum
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Complexion Repair Topical Rehydrating Emulsion which…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.