Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class III · Low risk
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE…
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Class III · Low risk
Lisinopril Tablets USP
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Failed Dissolution Specifications
Class III · Low risk
Oxycodone HCl
Failed Impurities/Degradation Specification; 9 month stability
Class III · Low risk
Doxycycline
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Class III · Low risk
Divalproex Sodium Delayed-release Tablets USP
Failed Tablet/Capsule Specifications
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Clotrimazole 1%/ Betamethasone Dipropionate 0.05% Otic Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Quad-Mix #3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 3
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vitamin B Complex # 1
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Vancomycin 50mg/Ml Ophth Solution
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 6
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 5
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Tri-Mix # 4
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.