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 drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
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Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.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.
Class III · Low risk
Finasteride Tablets
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class III · Low risk
Temazepam Capsules USP
Failed Stability Specifications
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Pantoprazole Sodium for Injection
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
Class III · Low risk
VirtPrex Prenatal/Postnatal Tablets
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Virt-Select Prenatal/Postnatal Softgels
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class III · Low risk
Extra-Virt Plus DHA Prenatal/Postnatal Softgel
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.