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Showing 3461–3480 of 14370 results

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Calcium Gluconate 10% 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

Methylcobalamin 12.5mg/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

Chantix 1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

MIC/B12A/B6 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

Carvedilol 25mg Tablets (Zydus) – Foreign Tablet Contamination (2021)

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Class IIModerate

FDAAug 13, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Chantix 0.5mg/1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Methylcobalamin Injection (Red Mountain) – Sterility Concern (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 Acid (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

Testosterone Cypionate (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

Testosterone Ultra (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 Selenite 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

Testosterone Blend (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

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Cyclosporine Ophthalmic (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

Glutathione (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

Magnesium Chloride (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

Folic Acid 10mg/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

Vitamin B Complex 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

Benzalkonium Chloride 0.013% 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

Calcium Chloride 100mg/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

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