Class III · Low risk Terminated
Fluocinonide Ointment USP 0.05%
Reason Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Class III · Low risk Terminated
Metformin Hydrochloride Tablets USP
Reason Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class III · Low risk Terminated
Cystaran
Reason Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Class III · Low risk Terminated
Homeopathic Energy Catalyst
Reason Labeling: Product Contains Undeclared API; Incorrect formulation
Class III · Low risk Terminated
Nymalize
Reason Subpotent Drug
Class III · Low risk Terminated
Citalopram Oral Solution
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Class III · Low risk Terminated
Nicotine Gum
Reason 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 Terminated
Extra Strength Headache Relief
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk Terminated
Pain Relief Maximum Strength
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk Terminated
Red Cross Oral Pain
Reason 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 Terminated
Clobetasol Propionate Cream
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class III · Low risk Terminated
Leucovorin Calcium Tablets USP
Reason Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class III · Low risk Terminated
Fosaprepitant for Injection
Reason 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 Terminated
Clonazepam Orally Disintegrating Tablets
Reason Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Class III · Low risk Terminated
Skin Medica Acne System
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk Terminated
Skin Medica Acne Treatment Lotion
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Class III · Low risk Terminated
Tecfidera
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk Terminated
Famotidine Injection
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk Terminated
Nabumetone Tablets
Reason Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Class III · Low risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason 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.