Class III · Low risk Terminated
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN…
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Good to Go Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class III · Low risk Terminated
Clonidine HCL Injection
Reason Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class III · Low risk Terminated
Thallous Chloride TI 201 Injection
Reason Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class III · Low risk Terminated
Biotin 10 mg/mL Injection
Reason Failed pH Specification: product does not meet pH label claim.
Class III · Low risk Terminated
Diclofenac Sodium Topical Solution
Reason Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class III · Low risk Terminated
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15
Reason Defective container: Ineffective seal between the cap and jar of the affected product.
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Clindamycin Injection
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Cleocin Phosphate
Reason Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Class III · Low risk Terminated
Testosterone Topical Solution
Reason Defective Container: Repetitive complaints received indicating pump not working.
Class III · Low risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Subpotent Drug.
Class III · Low risk Terminated
Mirapex
Reason Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class III · Low risk Terminated
ATHLETICARE Anti-Bacterial Hand Soap AC 550
Reason Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class III · Low risk Terminated
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; 9-monthstability timepoint