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Showing 101–120 of 128 results

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Precision Protein Cookies & Cream (Hi Tech Pharmaceuticals) – Incorrect Gluten Claim (2021)

During an inspection by the FDA the firm was notified by FDA that the product contains contains wheat but the label states it is "Gluten Free".

FDAApr 3, 2021AL, AZ, AR +41 more• Hi Tech Pharmaceuticals

ISOMORPH Whey Isolate Chocolate (Hi Tech) – undeclared allergens (2021)

Undeclared Milk

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

FDAApr 3, 2021AL, AZ, AR +41 more

• Hi Tech Pharmaceuticals

ISOMORPH Whey Isolate Cookies N Cream (Hi Tech) – undeclared allergens (2021)

Undeclared Milk

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

FDAApr 3, 2021AL, AZ, AR +41 more• Hi Tech Pharmaceuticals

ISOMORPH Whey Isolate Cinnamon Graham Cracker (Hi Tech) – undeclared allergens (2021)

Undeclared Milk

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

FDAApr 3, 2021AL, AZ, AR +41 more• Hi Tech Pharmaceuticals

ISOMORPH Whey Isolate Banana Cream Pie (Hi Tech) – undeclared allergens (2021)

Undeclared Milk

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

FDAApr 3, 2021AL, AZ, AR +41 more• Hi Tech Pharmaceuticals

ISOMORPH Whey Isolate Honey Granola (Hi Tech) – undeclared allergens (2021)

Undeclared Milk

During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy.

FDAApr 3, 2021AL, AZ, AR +41 more• Hi Tech Pharmaceuticals

Thumbs Up 7 Black (Nuri Trading) - Undeclared Ingredients (2021)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.

FDAMar 29, 2021Nationwide• Nuri Trading LLC

69MODE Blue 69 (Nuri Trading) - Undeclared Ingredients (2021)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

FDAMar 29, 2021Nationwide• Nuri Trading LLC

Shogun-X 7000 (Nuri Trading) - Undeclared Ingredients (2021)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

FDAMar 29, 2021Nationwide• Nuri Trading LLC

Thumbs Up 7 White (Nuri Trading) - Undeclared Ingredients (2021)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

FDAMar 29, 2021Nationwide• Nuri Trading LLC

Enoxaparin Sodium (Apotex) – labeling mixup (2021)

Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)

FDAFeb 2, 2021Nationwide• Apotex Corp.

Enoxaparin Sodium (Apotex) – labeling mixup (2021)

Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)

FDAFeb 2, 2021Nationwide• Apotex Corp.

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Montelukast Sodium Tablets (Hetero Labs) – label mix-up (2018)

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

FDAAug 15, 2018Nationwide• Hetero Labs Limited Unit V

Infant Dextrose Injection (Hospira) – Particulate Matter (2017)

Presence of Particulate Matter: human hair found within an internal sample syringe.

FDAApr 21, 2017Nationwide• Hospira Inc.

EpiPen (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

EpiPen Jr. (Meridian Medical) – Defective Delivery (2017)

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

FDAMar 12, 2017Nationwide• Meridian Medical Technologies a Pfizer Company

Bupivacaine (Hospira) – Particulate Matter (2016)

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

FDAAug 4, 2016Nationwide• Hospira Inc., A Pfizer Company

HCG Injection (Complete Pharmacy) – Non-sterility (2016)

Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

FDAApr 2, 2016Nationwide• Complete Pharmacy and Medical Solutions LLC

Magnesium Sulfate Injection (Hospira) – Particulate Matter (2016)

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

FDAMar 23, 2016Nationwide• Hospira Inc.

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