Class III · Low risk
PreviDent 5000 ppm
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
FDA Drug Recalls
165 recalls · Class III, newest first
Class III · Low risk
Salicylic Acid Cream
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk
Salicylic Acid Shampoo
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk
Levofloxacin Ophthalmic Solution
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class III · Low risk
Q Care Continue Care Kit for the non-ventilated patient
Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Class III · Low risk
Norethindrone Acetate and Ethinyl Estradiol Tablets
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Tarina Fe 1/20
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Buffered Lidocaine
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Class III · Low risk
Taclonex (calcipotriene and betamethasone dipropionate)
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Class III · Low risk
Dexamethasone Elixir
Failed Impurities/ Degradation Specifications
Class III · Low risk
Albuterol Sulfate Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Class III · Low risk
Dye Free Allergy Softgel Gelatin Capsule
Subpotent
Class III · Low risk
Diphenhydramine HCl 25 mg
Subpotent
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.