Class III · Low risk Terminated
Clotrimazole and Betamethasone Dipropionate Cream USP
Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Sapropterin Dihydrochloride Powder for Oral Solution
Reason Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class III · Low risk Terminated
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Reason Subpotent drug
Class III · Low risk Terminated
Bortezomib
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class III · Low risk Terminated
Mucus Relief D
Reason Subpotent drug
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class III · Low risk Terminated
Leader
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
CVS Health
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Qc Quality Choice
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
equate
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Dr. Reddys
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Kroger
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rite Aid Pharmacy
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rugby
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Wal-Fex D
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Oxycodone Hydrochloride Tablets
Reason Out-of-specification impurity test result observed at 18-month long term stability time point.
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class III · Low risk Terminated
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CariFree sample boxes
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx36 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx26 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk Terminated
CTx21 Kit
Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.