Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
meijer
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Foster & Thrive
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Leader
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Good Neighbor Pharmacy
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
FAMILY Wellness
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Audiologist's Choice
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
TopCare Health
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
QC Quality Choice
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Clinere
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
CVS Health
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class I · High risk
Cetirizine Hydrochloride Tablets USP 5 mg
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Bortezomib for Injection 3.5mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 500mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Methohexital Sodium
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base