Loading…
Loading…
Home › All recalls › Over-the-counter & supplements
Category
Pain relief, cold remedies, vitamins, dietary supplements.
Or try another category
425 recalls · newest first
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
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.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
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.
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
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.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and…
Discoloration
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
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.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
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.
Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol