Other Drugs

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

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.

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.

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.

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.

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.

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Labeling: Not Elsewhere Classified

Defective Container

Product Mix-up

Marketed Without an Approved NDA/ANDA

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Subpotent Drug

Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.

cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Cross Contamination with Other Products.

Cross Contamination with Other Products.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Defective Container: broken or leaking bottles.

cGMP violations

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 64.

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 64.

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

CGMP Deviations

CGMP Deviations

CGMP Deviations

cGMP deviations

cGMP deviations

cGMP deviations

cGMP deviations

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.

Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations