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Showing 301–320 of 548 results

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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

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

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

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

Reumo Flex Caplets (Botanical Be) – undeclared ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

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 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 Dryness 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 Lid Relief (Amman) – 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 Pink 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 Pink Eye 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 Blur Relief (Amman) – 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

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

OTC Drug Products (Inmar) – potential rodent exposure (2023)

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Class IIModerate

FDAAug 14, 2023Nationwide• Inmar Supply Chain Solutions, LLC

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