Class III · Low risk Terminated
FOLLOW YOUR DREAMS! Justice
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Girls can change the World
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk Terminated
Shine from within blueberry Anti bac Justice
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk Terminated
Share a Smile Mixed berry Anti bac Justice
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk Terminated
Believe in Yourself Strawberry Anti bac Justice
Reason Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk Terminated
Amoxicillin for Oral Suspension
Reason Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Class III · Low risk Terminated
Prednisone Tablet USP
Reason Labeling: Missing Label; missing label on blister card
Class III · Low risk Terminated
Medroxyprogesterone acetate
Reason Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Class III · Low risk Terminated
Fentanyl Transdermal System
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Prempro
Reason Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
Class III · Low risk Terminated
Prempro
Reason Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Class III · Low risk Terminated
Norpace CR
Reason Failed Dissolution Specification
Class III · Low risk Terminated
Pharmalucence Kit for the Preparation of Technetium Tc 99m…
Reason Presence of Particulate Matter; particulate found in retain samples
Class III · Low risk Terminated
Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units
Reason Failed Stability Specifications: Unable to meet shelf life expiry.
Class III · Low risk Terminated
Folic Acid Injection
Reason Failed Impurities/Degradation Specification
Class III · Low risk Terminated
Excedrin
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk Terminated
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Theraflu Warming Relief
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk Terminated
Maximum Strength Comtrex
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex Nighttime Cold & Cough
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Maximum Strength Comtrex Day/Night Cold & Cough
Reason Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk Terminated
Budesonide Capsules
Reason Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Class III · Low risk Terminated
Nicardipine Hydrochloride Injection 25 mg/10 mL
Reason Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Class III · Low risk Terminated
Derma-Smoothe/FS
Reason Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.