Class III · Low risk
Fluocinonide Ointment USP 0.05%
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
FDA Drug Recalls
94 recalls · Class III, newest first
Class III · Low risk
Nystatin Oral Suspension
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class III · Low risk
Cystaran (cysteamine ophthalmic solution)
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class III · Low risk
Homeopathic Energy Catalyst
Labeling: Product Contains Undeclared API; Incorrect formulation
Class III · Low risk
Nymalize (nimodipine)
Subpotent Drug
Class III · Low risk
Citalopram Oral Solution
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class III · Low risk
Nicotine Gum
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Class III · Low risk
Extra Strength Headache Relief
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Pain Relief Maximum Strength
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Red Cross Oral Pain
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Class III · Low risk
Clobetasol Propionate Cream
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class III · Low risk
Fosaprepitant for Injection
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Class III · Low risk
Clonazepam Orally Disintegrating Tablets
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Class III · Low risk
Skin Medica Acne System
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk
Skin Medica Acne Treatment Lotion
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk
Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk
Nabumetone Tablets
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Class III · Low risk
Prednisolone Sodium Phosphate Oral Solution
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class III · Low risk
Brimonidine Tartrate Opthalmic Solution 0.2%
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.