Class III · Low risk Terminated
Bronkaid Dual Action Formula
Reason Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Clean & Clear advantage
Reason Superpotent (Single Ingredient Drug): salicylic acid
Class III · Low risk Terminated
Carisoprodol Tablets
Reason Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Class III · Low risk Terminated
TORISEL Kit
Reason Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Class III · Low risk Terminated
Derma-Smoothe/FS
Reason Subpotent; 22 month stability timepoint
Class III · Low risk Terminated
Derma-Smoothe/FS
Reason Subpotent; 12 month stability timepoint
Class III · Low risk Terminated
EstroGel
Reason Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Class III · Low risk Terminated
Advair HFA
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk Terminated
Advair HFA
Reason Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk Terminated
ESTEE LAUDER DayWear Sheer Tint Release
Reason Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Class III · Low risk Terminated
AcneFree Acne Pore Cleanser
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree Severe Maximum Strength Acne Pore Cleanser
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree 3-in-1 Acne Night Repair Foam
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree Acne Astringent Toner Pads
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Class III · Low risk Terminated
AcneFree Original Strength Terminator
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree Oil-Free Acne Cleanser
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz
Reason Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Class III · Low risk Terminated
Lemon Hand Sanitizing Wipes
Reason CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Class III · Low risk Terminated
CellCept
Reason Short Fill: some bottles contained less than 120-count per labeled claim.
Class III · Low risk Terminated
Children's Cetirizine HCl Chewable Tablets 5 mg
Reason Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Class III · Low risk Terminated
Pramipexole Dihydrochloride Tablets
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk Terminated
Pramipexole Dihydrochloride Tablets
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk Terminated
Enalapril Maleate Tablet
Reason Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Class III · Low risk Terminated
Novarel¿
Reason Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.