1,709 recalls · Class III, newest first
Reason Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Reason Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Reason Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Reason Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Reason Labeling: Product Contains Undeclared API; Incorrect formulation
Reason Subpotent Drug
Reason Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
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…
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
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…
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Reason Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Reason Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium…
Reason Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Reason SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Reason Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Reason Discoloration: Out of Specification (OOS) result for APHA Color Test.
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over…