Class II · Moderate risk
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU…
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
FDA Drug Recalls
1,055 recalls · Class II, newest first
Class II · Moderate risk
Dermamedics Post Procedure Cream
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Heparin Sodium 2000 USP Heparin Units per 1000 mL
Lack of Assurance of Sterility; potential leakage from administrative port.
Class II · Moderate risk
Aminosyn 3.5% M Sulfite-Free
Lack of Assurance of Sterility; potential leakage from administrative port.
Class II · Moderate risk
a) Walgreens Lansoprazole Delayed Release Capsules
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.