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425 recalls · newest first
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection…
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…
CGMP deviations
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
CGMP Deviations
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.
Discoloration: Brownish tablets
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Marketed Without An Approved NDA/ANDA
Out of Specification for active ingredient
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.