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Showing 1261–1280 of 3363 results

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Bupropion Extended-Release Tablets (Jubilant) – Dissolution Failure (2019)

Failed Dissolution Specifications; 9-monthstability timepoint

FDAFeb 28, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Moxifloxacin Ophthalmic Solution (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

FDAFeb 26, 2019Nationwide• Lupin Pharmaceuticals Inc.

Oxybutynin Chloride Tablets (Lannett) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIILow

FDAFeb 21, 2019Nationwide• Lannett Company Inc.

Lovastatin Tablets USP (American Health Packaging) – CGMP Deviations (2019)

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

FDAFeb 19, 2019Nationwide• American Health Packaging

Temozolomide Capsules (Amerigen) – Failed Dissolution (2019)

Failed dissolution specifications

FDAFeb 19, 2019Nationwide• Amerigen Pharmaceuticals Inc.

Diltiazem Capsules (Mylan) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

FDAFeb 13, 2019Nationwide• Mylan Pharmaceuticals Inc.

Lovastatin Tablets (Lupin) – CGMP Deviations (2019)

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

FDAFeb 13, 2019Nationwide• Lupin Pharmaceuticals Inc.

Ciclopirox Shampoo (Perrigo) – Substance Deviation (2019)

Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.

FDAFeb 13, 2019Nationwide• Perrigo New York, Inc.

Mometasone Cream (ACP) – Labeling Error (2019)

Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

FDAFeb 7, 2019Nationwide• ACP Nimble Buyer, Inc.

Esomeprazole Capsules (Dr. Reddy's) – Color Deviation (2019)

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

FDAFeb 6, 2019Nationwide• Dr. Reddy's Laboratories, Inc.

Oxytocin NS 1000 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Oxytocin NS 500 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Oxytocin NS 1000 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Moxifloxacin Eye Drops (Lupin) – Impurity Concerns (2019)

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

FDAFeb 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Enjuku Koji Miso Mutenka (Hikari Miso) – Undeclared Soy (2019)

Miso product manufactured in Japan was distributed in US with no English labeling and therefore soy beans not properly declared on label as an allergen.

FDAFeb 1, 2019CA, IN• Hikari Miso International, Inc.

Cardizem CD 240mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 300mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 180mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Diltiazem HCl CD 360mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 120mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

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