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Ful-Glo (Nomax) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Class IIModerate

FDAApr 19, 2024Nationwide• Nomax Inc

Ful-Glo (Nomax) – Impurity Specification Failure (2024)

Class IIModerate

FDAApr 19, 2024Nationwide

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Ful-Glo (Nomax) – Impurity Specification Failure (2024)

Ful-Glo (Nomax) – Impurity Specification Failure (2024)

GloStrips (Nomax) – Impurity Specification Failure (2024)

GloStrips (Nomax) – Impurity Specification Failure (2024)

Amphotericin B Liposome (Sun Pharmaceutical) – Assay Issue (2024)

Diltiazem Hydrochloride (Glenmark) – Dissolution Failure (2024)

Prednisolone-Moxifloxacin-Bromfenac Solution (Imprimis) – Subpotent Drug (2024)

Epinephrine-Lidocaine HCl Solution (Imprimis) – Assay Specification (2024)

Abilify 15mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 30mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 5mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 10mg Tablets (Otsuka) – Product Contamination (2024)

Sapropterin Dihydrochloride Powder (Dr. Reddy's) – Sub-potent Drug (2024)

Javygtor Oral Powder (Dr. Reddy's) – Sub-potent Drug (2024)

ELV Control Herbal Supplement (World Green Nutrition) – Toxic Ingredient (2024)

Isotretinoin 40mg Capsules (Teva) – Superpotent Drug (2024)

Lansoprazole Capsules (NATCO) – Manufacturing Deviation (2024)

Diltiazem Extended-Release Capsules (Glenmark) – Dissolution Failure (2024)

Alcoholada Gel (Aruba Aloe) – Methanol Contamination (2024)

Spanish Fly Capsules (Pyramids) – Undeclared Drug Ingredients (2024)