Class I - Dangerous
Microbial contamination
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.
Dr. Reddy's Laboratories
Class I - Dangerous
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination