Class II · Moderate risk
Hydromorphone HCL 10 mg/ml
Lack of Assurance of Sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 25 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 20 mg/ml/Bupivacaine HCL 40 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 2000 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Bupivacaine HCL 30 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 0.6 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone 12 mg/ml/Baclofen 450 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 5000 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Menthocin Patch with Lidocaine-Strong
Marketed without an approved NDA/ANDA
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class II · Moderate risk
Nystatin
Labeling: label error on declared strength.
Class II · Moderate risk
Levofloxacin Tablets USP
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class II · Moderate risk
papaverine phent
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
testosterone cypionate
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
testosterone cypionate
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.