Class II · Moderate risk
Travoprost Ophthalmic Solution USP
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class II · Moderate risk
Phenobarbital Tablets
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class III · Low risk
Paricalcitol Capsules
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
Class II · Moderate risk
USCG Boat Response Kit - Product Code 80-0353
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Aid Backpack Kit - Product Code 85-0917
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Mini Resupply Trauma Kit - Product Code 85-0835
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Amphibious Trauma Kit - Product Code 85-0639
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
K-9 Trauma Field Kit - Product Code 80-0211
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Advance Trauma Kit - Product Code 85-0742
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit - Product Code 85-1274
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit ORG - Product Code 80-0213
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II · Moderate risk
Range Trauma Kit Hardcase - Product Code 85-0889
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class III · Low risk
Gildess 24 FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class III · Low risk
PARICALCITOL Capsules
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Class II · Moderate risk
Testosterone Cypionate in Sesame Oil Injectable
Lack of Assurance of Sterility