Class II · Moderate risk Terminated
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Baclofen 5000 mcg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Menthocin Patch with Lidocaine-Strong
Reason Marketed without an approved NDA/ANDA
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class II · Moderate risk Terminated
Nystatin
Reason Labeling: label error on declared strength.
Class II · Moderate risk Terminated
Nystatin
Reason Labeling: label error on declared strength.
Class II · Moderate risk Terminated
Levofloxacin Tablets USP
Reason Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class II · Moderate risk Terminated
papaverine phent
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
testosterone cypionate
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
testosterone cypionate
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
progesterone/testosterone
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk Terminated
papaverine phentolamine prostaglandin
Reason Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.