Class I · High risk Terminated
Cubicin
Reason Presence of Particulate Matter: Identified as Glass Particles
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk Terminated
Rizatriptan Benzoate Film Coated Tablets
Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk Terminated
Ezetimibe and Simvastatin Tablets
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class III · Low risk Terminated
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Xpect First aid Extra Strength PAIN AWAY
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
Advance Formula Pain Reliever
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
North by Honeywell PAIN STOPPER EXTRA STRENGTH
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk Terminated
AERO Tab PAIN RELIEVER
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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