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Showing 4641–4660 of 14370 results

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Cefdinir Oral Suspension 250mg (Lupin) – Dead Ant Found (2019)

Presence of Foreign substance: identified as a dead ant.

FDANov 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Cephalexin Oral Suspension (Lupin) – Dead Ant Found (2019)

Presence of Foreign substance: identified as a dead ant.

FDANov 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Ranitidine Syrup (American Health) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDANov 1, 2019Nationwide• American Health Packaging

Advanced Probiotic (Leader) – Incorrect Blend (2019)

Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label.

FDAOct 31, 2019Nationwide• Merical, LLC

LETS GEL KIT (Fagron) – Microbial Contamination (2019)

Microbial contamination of non-sterile product.

Class IIModerate

FDAOct 31, 2019Nationwide• Fagron, Inc

Potassium Phosphate (Avantor) – Exceeded Iron Specs (2019)

Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.

Class IIModerate

FDAOct 30, 2019Nationwide• Avantor Performance Materials Inc

Ranitidine Syrup (Lannett) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 28, 2019Nationwide• Lannett Company, Inc.

Ranitidine Capsules 300mg (Novitium) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 25, 2019Nationwide• Novitium Pharma LLC

Ranitidine Capsules 150mg (Novitium) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 25, 2019Nationwide• Novitium Pharma LLC

Ranitidine Capsules 300mg (Novitium) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 25, 2019Nationwide• Novitium Pharma LLC

Ranitidine Capsules 150mg (Novitium) – NDMA Impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 25, 2019Nationwide• Novitium Pharma LLC

Sodium Chloride Injection (ICU Medical) – Particulate Matter (2019)

Presence of Particulate Matter.

FDAOct 25, 2019Nationwide• ICU Medical Inc

Lactated Ringer's Injection (ICU Medical) – Particulate Matter (2019)

Presence of Particulate Matter.

FDAOct 25, 2019Nationwide• ICU Medical Inc

Taspen's Breathe Easy Tincture (Green Water) – Unsafe Ingredient (2019)

The products contain Coltsfoot, which is not to be used internally.

Class IIModerate

FDAOct 24, 2019Nationwide• Green Water, LLC

Dragonfly Breathe Deep Supplement (Green Water) – Unsafe Ingredient (2019)

The products contain Coltsfoot, which is not to be used internally.

Class IIModerate

FDAOct 24, 2019Nationwide• Green Water, LLC

Alprazolam Tablets (Mylan) – foreign substance risk (2019)

Presence of Foreign Substance

Class IIModerate

FDAOct 23, 2019Nationwide• Mylan Pharmaceuticals Inc.

Natural Fuel For Men Capsules (Green Lumber) – undeclared drug (2019)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

FDAOct 22, 2019Nationwide• Green Lumber Holdings, LLC

Estradiol Vaginal Inserts (Glenmark) – applicator defect (2019)

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Class IIModerate

FDAOct 22, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Atorvastatin Tablets (Apotex) – foreign tablet mix-up (2019)

Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

FDAOct 22, 2019IL, MS, NJ +2 more• Apotex Inc.

PF-Succinylcholine Chloride (Nephron) – Incorrect Labeling (2019)

Incorrect labeling: Incorrect or missing lot and/or exp date

FDAOct 21, 2019Nationwide• Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

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