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Showing 3481–3500 of 14370 results

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Methylcobalamin 5000mcg/ml Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Ascorbic/Glutathione 1.25% Ophth Solution (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Progesterone 100mg/ml Oil Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Sodium Bicarbonate Injection (SterRx) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 10, 2021Nationwide• SterRx, LLC

Sodium Bicarbonate Injection (SterRx) – Microbial Contamination (2021)

Non-Sterility: firm's third party lab confirmed microbial contamination.

FDAAug 10, 2021Nationwide• SterRx, LLC

Carbamazepine Tablets (Harvard Drug) – Dissolution Failure (2021)

Failed Dissolution Specifications

Class IIModerate

FDAAug 6, 2021NC• The Harvard Drug Group

Micafungin Injection 50mg (Xellia) – Incomplete Labeling (2021)

Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.

Class IIModerate

FDAAug 6, 2021Nationwide• XELLIA PHARMACEUTICALS USA, LLC

Micafungin Injection 100mg (Xellia) – Incomplete Labeling (2021)

Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.

Class IIModerate

FDAAug 6, 2021Nationwide• XELLIA PHARMACEUTICALS USA, LLC

Bleomycin Injection (Hikma) – Mislabeling Issue (2021)

Labeling: Not elsewhere classified: Mislabeling

FDAAug 5, 2021Nationwide• Hikma Pharmaceuticals USA Inc.

Lidocaine Topical Solution (Teligent) – Potency Problem (2021)

Superpotent Drug

FDAAug 3, 2021Nationwide• Teligent Pharma, Inc.

Fexofenadine Tablets (Harvard Drug) – Impurity Concern (2021)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAAug 3, 2021Nationwide• The Harvard Drug Group

Artificial Tears Ointment (Akorn) – Sterility Issue (2021)

Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.

Class IIModerate

FDAAug 2, 2021Nationwide• Akorn, Inc.

Clopidogrel Tablets (Macleods) – Foreign Matter (2021)

Presence of foreign matter

Class IIModerate

FDAAug 2, 2021Nationwide• Macleods Pharma Usa Inc

365 Skinny Capsules (Je Dois Lavoir) – Undeclared Ingredient (2021)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

FDAAug 2, 2021Nationwide• Je Dois Lavoir LLC

Fludarabine Injection (Custopharm) – Sterility Concern (2021)

Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

Class IIModerate

FDAJul 30, 2021Nationwide• Custopharm, Inc.

Combipatch 0.05/0.14mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Combipatch 0.05/0.25mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Succinylcholine Chloride (BayCare) – Sterility Risk (2021)

Lack of sterility assurance

Class IIModerate

FDAJul 30, 2021FL• BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Epoprostenol Sodium (Teva) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 29, 2021Nationwide• Teva Pharmaceuticals USA

Cyclobenzaprine Hydrochloride Tablets (Teva) – Microbial Contamination (2021)

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Class IIModerate

FDAJul 29, 2021Nationwide• Teva Pharmaceuticals USA

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