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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
This recall involves Safetussin Max Strength Multi-Symptom Cough, Cold and Flu 24-count caplet blister packs. They are labeled with "Safetussin," "Multi-Symptom," "Cough, Cold & Flu" and "Safe for adults with High Blood Pressure, Diabetes." They were sold in a blue, orange and red cardboard box with the drug facts label on the back.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Subpotent
Subpotent
Subpotent
Subpotent
CGMP Deviations
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
CGMP Deviations
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of Assurance of Sterility: Leaking/damaged syringes.