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Showing 3341–3360 of 14370 results

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BCAA Amino Acids Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Alprostadil 45mcg Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

TRI-MIX Papaverine 20 Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

MIC B Complex Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Irbesartan Hydrochlorothiazide Tablets (Lupin) – impurity detected (2021)

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Class IIModerate

FDAOct 12, 2021Nationwide• Lupin Pharmaceuticals Inc.

Sermorelin Ipamorelin Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Alprostadil 30mcg Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Goal-Glutamine Amino Acids Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Methylcobalamin 5mg Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Alprostadil Injectable (Talon) – sterility risk (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Tri-Mix Papaverine Injection (Talon Compounding) – Sterility Concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Methylcobalamin Injection (Talon) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Test Cypionate Blend (Talon) – sterility risk (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Testosterone Cypionate Blend (Talon) – sterility risk (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Tri-Mix Injection (Talon) – sterility risk (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Quad-Mix Injection (Talon) – sterility risk (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Test Cypionate Injection (Talon Compounding) – Sterility Concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Ultra-Test Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

CJC-1295/Ipamorelin (Talon Compounding) – Sterility Issue (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Estradiol Valerate Injectable (Talon Compounding) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

FDAOct 12, 2021Nationwide• Vita Pharmacy, LLC dba Talon Compounding Pharmacy

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