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Showing 901–920 of 3363 results

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Doxorubicin Hydrochloride (Fresenius Kabi) – Cross Contamination (2020)

Cross Contamination with Other Products: trace amounts of octreotide found during testing

FDANov 17, 2020Nationwide• Fresenius Kabi USA, LLC

Coleslaw (Presidents Choice) – processing deviation (2020)

CCP deviation with the wash process

FDANov 14, 2020IN• Dole Fresh Vegetables Inc

Testosterone Gel (Teva) – Superpotent Medication (2020)

Superpotent Drug: High out-of-specification assay results were obtained during stability testing.

Class IIILow

FDANov 11, 2020Nationwide• Teva Pharmaceuticals USA

Levocetirizine Tablets (InvaTech) – Stability Failure (2020)

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

FDANov 11, 2020Nationwide• InvaTech Pharma Solutions, LLC

Clobetasol Ointment (Teligent) – Potency Variation (2020)

Superpotent and Subpotent; low and high assay results

FDANov 5, 2020Nationwide• Teligent Pharma, Inc.

Triamcinolone Lotion (Teligent) – Subpotent Medication (2020)

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

FDANov 3, 2020Nationwide• Teligent Pharma, Inc.

Olanzapine ODT (Jubilant) – Subpotent Medication (2020)

Subpotent

FDAOct 26, 2020Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Felodipine Extended Release 10mg (Heritage) – Impurity Specifications (2020)

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

FDAOct 23, 2020Nationwide• Heritage Pharmaceuticals Inc

Children's Ibuprofen Suspension (Aurobindo) – Missing Dosing Cups (2020)

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

FDAOct 22, 2020NJ• Aurobindo Pharma USA Inc.

Classic Coleslaw (Aldi) – Processing Deviation (2020)

CCP deviation associated with wash process, portion of affected product left company control.

FDAOct 22, 2020CT, MI, OH +2 more• Dole Fresh Vegetables Inc

Premium Teriyaki Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Szechuan Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Ponzu Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Premium Shoyu Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Eurasian Fusion Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Tangy Teriyaki Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Tsukeyaki Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Yakitori Sauce (Chef Myron's) – Gluten Mislabeling (2020)

Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.

FDAOct 21, 2020Nationwide• JMH International, LLC

Cream Tech 250 Sour Cream Stabilizer (Denali Ingredients) – Incorrect Ingredient (2020)

Stabilizer was made with Citric Acid instead of Sodium Citrate.

FDAOct 19, 2020FL, OH• Denali Ingredients LLC

Supreme1251 Coffee Cream Stabilizer (Denali Ingredients) – Incorrect Ingredient (2020)

Stabilizer was made with Citric Acid instead of Sodium Citrate.

FDAOct 19, 2020FL, OH• Denali Ingredients LLC

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