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Showing 4501–4520 of 14370 results

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Betamethasone Injectable (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Selenium Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Glutathione Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Glycine Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Methionine Inositol Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Alprostadil Injectable (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Human Chorionic Gonadotropin Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Cyanocobalamin Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Levocarnitine Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Iohexol Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Hydroxocobalamin Injection (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Triamcinolone/Bupivacaine Injectable Suspension (Fusion IV Pharmaceuticals) – Sterility Concern (...

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Nicotinamide Adenine Dinucleotide Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Arginine Hydrochloride Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Ranitidine 150mg Tablets (Direct Rx) – NDMA Impurity (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAJan 15, 2020FL, GA• Direct Rx

MIC-B12 Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

MIC-PLEX Injection (Fusion IV Pharmaceuticals) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lidocaine HCL Injection (Fusion IV) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Dexamethasone Injectable Suspension (Axia Pharmaceutical) – Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAJan 15, 2020Nationwide• Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Adaptogems Peach Blossom Lozenges (Kindroot) – Unlisted Ingredient (2020)

Inspection by California Department of Public Health found that product label did not include fish as the source of collagen peptides.

Class IIModerate

FDAJan 15, 2020AK, CA, CO +4 more• Kindroot LLC

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