CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

Class IIModerate

FDAOct 12, 2021Nationwide• Teligent Pharma, Inc.

Tri-Mix Papaverine Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

Quad-Mix Papav Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

Tri-Mix Papav Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

L-Carnitine Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

IVME Super B Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

Estradiol Valerate 40mg/mL Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

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

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Class IIModerate

FDAOct 12, 2021Nationwide• Lupin Pharmaceuticals Inc.

MIC B Complex Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

Testosterone Cypionate 100mg/mL Injectable (Talon Compounding) – sterility concerns (2021)

Lack of assurance of sterility

Class IIModerate

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

MIC B Complex (Talon Compounding) – Sterility Concern (2021)

Lack of assurance of sterility

Class IIModerate

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

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

Lack of assurance of sterility

Class IIModerate

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

TRI-MIX Papaverine 15 Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

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

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