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Showing 2741–2760 of 14370 results

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Rifampin Injection (Mylan) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.

Class IIModerate

FDAApr 7, 2022Nationwide• Mylan Pharmaceuticals Inc

Losartan Potassium Tablets (RemedyRepack) – AZIDO Impurity (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Class IIModerate

FDAApr 6, 2022AK, IN, PA• RemedyRepack Inc.

Trulicity Injection (Cardinal) – Temperature Abuse (2022)

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

Class IIModerate

FDAApr 5, 2022NM• Cardinal Health Inc.

Sermorelin Acetate Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

ARA-290 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

PT-141 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Humalog KwikPen (Cardinal) – Temperature Abuse (2022)

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.

FDAApr 5, 2022NM• Cardinal Health Inc.

Cyanocobalamin Injection (Aurobindo) – Subpotent Drug (2022)

Subpotent Drug: Out of Specification results for Assay

FDAApr 5, 2022Nationwide• Aurobindo Pharma USA Inc.

LL-37 Injection (FarmaKeio) – Sterility Concerns (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

BPC-157 Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Trulicity Injection (Cardinal) – Temperature Abuse (2022)

TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions

Class IIModerate

FDAApr 5, 2022NM• Cardinal Health Inc.

Melanotan II Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Ipamorelin/Sermorelin Injection (FarmaKeio) – Sterility Concern (2022)

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Class IIModerate

FDAApr 5, 2022Nationwide• North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

NAD+ Nicotinamide Dinucleotide (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

T-101 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

SB-6 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Phenylephrine Solution (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Formula F9 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

QM-2 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

T-105 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

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