Class II · Moderate risk
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
FDA Drug Recalls
12 recalls · Class II, newest first
Class II · Moderate risk
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Coppertone SUNSCREEN LOTION
Labeling; Product Contains Undeclared API (Oxybenzone)
Class II · Moderate risk
3rd DEGREE capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class II · Moderate risk
Cisatracurium Besylate Injection
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Class II · Moderate risk
Potassium Chloride Injection 20 mEq
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Mannitol I.V.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Aminosyn-PF
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk
Dextrose Injection
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.