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Showing 41–60 of 128 results

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VitalityXtra Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide• Boulla LLC

ZoomMax Capsules (Boulla) – Undeclared Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

FDANov 4, 2024Nationwide

• Boulla LLC

Vail-Bon Jie Yang Wan Capsules (123Herbals) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

FDASep 18, 2024Nationwide• 123Herbals

Heparin Sodium Injection (Baxter) – Endotoxin Contamination (2024)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

FDAAug 1, 2024Nationwide• Baxter Healthcare Corporation

Sodium Chloride Injection (B. Braun) – Particulate Matter (2024)

Presence of Particulate Matter

FDAJul 24, 2024Nationwide• B. Braun Medical Inc

Hard Steel Capsules (Supercore) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

FDAJul 12, 2024Nationwide• Supercore Products Group Inc.

Gold Hard Steel Plus (Supercore) – Undeclared Drugs (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

FDAJul 12, 2024Nationwide• Supercore Products Group Inc.

Acetaminophen (Aurobindo) – Missing Label (2024)

Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

FDAJul 11, 2024NJ, NY, PA• Aurobindo Pharma USA Inc

Acetaminophen Injection (Hikma) – Label Mix-up (2024)

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

FDAJul 8, 2024OH, PR• Hikma Pharmaceuticals USA Inc.

Potassium Chloride Capsules (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications

FDAJun 25, 2024Nationwide• Amerisource Health Services LLC

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Tirzepatide (Revive Rx) – Labeling Mix-up (2024)

Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate

FDAApr 20, 2024Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

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

Sub-potent Drug; powder discoloration associated with decreased potency

FDAApr 8, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

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

Sub-potent Drug; powder discoloration associated with decreased potency

FDAApr 8, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

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

FDA Analysis found product labeled as tejocote is actually yellow oleander, which is toxic to humans.

FDAApr 3, 2024DE, OR• World Green Nutrition Inc.

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

Chemical Contamination: Product manufactured with ethanol API that contains methanol

FDAMar 23, 2024Nationwide• Aruba Aloe Balm N.V.

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

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

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