Class III · Low risk Terminated
AERO Tab PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
ZEE+ painaid ESF Extra-Strength Formula
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Vica-Cet BACK PAIN RELIEF
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
PainAway II
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class I · High risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4%
Reason Superpotent Drug
Class II · Moderate risk Terminated
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Class II · Moderate risk Terminated
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 60 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 5 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 20 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 30 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 3/Pge-1 100 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 60 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 50 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 30 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 2/Pge-1 20 Inj **t 104** Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 5 Inj Injectable
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Tri-Mix Papaverine 30/Phentolamine 1/Pge-1 40 Inj Injectable
Reason Lack of assurance of sterility