Class III · Low risk
Gatifloxacin Ophthalmic Solution
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
FDA Drug Recalls
1,058 recalls, newest first
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class II · Moderate risk
Diclofenac Sodium Topical Solution USP
Defective Container
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class III · Low risk
Rizatriptan Benzoate Film Coated Tablets
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
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
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Xpect First aid Extra Strength PAIN AWAY
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Advance Formula Pain Reliever
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
North by Honeywell PAIN STOPPER EXTRA STRENGTH
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
AERO Tab PAIN RELIEVER
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
ZEE+ painaid ESF Extra-Strength Formula
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Vica-Cet BACK PAIN RELIEF
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
PainAway II
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
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
Lidocaine Hydrochloride Topical Solution USP 4%
Superpotent Drug
Class II · Moderate risk
Lidocaine Hydrochloride Topical Solution USP 4%
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
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 40 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 40/Phentolamine 2/Pge-1 10 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 6/Pge-1 60 Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 7.5/Ml Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Tri-Mix Papaverine 30/Phentolamine 4/Pge-1 60 Inj Injectable
Lack of assurance of sterility