Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.

Class IIModerate

FDAJan 10, 2024Nationwide• MEDLINE INDUSTRIES, LP - Northfield

Magnesium Citrate Laxative (Walgreens) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Freskaro Magnesium Citrate Laxative Chewable (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Freskaro Magnesium Citrate Laxative (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Good Neighbor Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

CVS Health Magnesium Citrate Laxative (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

Himalayan Pain Relief Tea (WS Global) – Undeclared Drugs (2023)

Undeclared Allergen

Contains undeclared drugs Diclofenac and Dexamethasone Acetate

Class IIModerate

FDADec 13, 2023Nationwide• WS Global Inc

OTC Drug Products (Dollar Tree) – Temperature Storage Violation (2023)

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

Class IIModerate

FDAOct 5, 2023Nationwide• Dollar Tree Distribution, Inc.

TRP Natural Eyes Dryness Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Lid Relief (Amman) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Aging Eye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Red Eye Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Allergy Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Allergy Relief PF (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

TRP Natural Eyes Floaters Relief (Amman Pharmaceuticals) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDASep 1, 2023CO, IN, RI• AMMAN PHARMACEUTICAL INDUSTRIES

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