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Showing 3281–3300 of 14370 results

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PainAway II (Ultra Seal) – Stability Specification Failure (2021)

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

FDAOct 13, 2021Nationwide• Ultra Seal Corporation

AERO Tab Pain Reliever (Ultra Seal) – Stability Specification Failure (2021)

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

FDAOct 13, 2021Nationwide• Ultra Seal Corporation

ZEE+ Painaid ESF (Ultra Seal) – Stability Specification Failure (2021)

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Class IIILow

FDAOct 13, 2021Nationwide• Ultra Seal Corporation

Loratadine-D Tablets (Sun Pharmaceutical) – Moisture Limits Failed (2021)

Failed Moisture Limits

FDAOct 12, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Hydroxocobalamin 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 Hydroxocobalamin Injection (Talon) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

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

Testosterone Cypionate with Anastrozole (Talon Compounding) – sterility concern (2021)

Lack of assurance of sterility

Class IIModerate

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

Lidocaine Hydrochloride Topical Solution (Teligent) – Superpotent Drug (2021)

Superpotent Drug

FDAOct 12, 2021Nationwide• Teligent Pharma, Inc.

B Complex Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Alprostadil Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Tri-Test 200 Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Test Cypionate Combination (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Testosterone Cypionate Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Test Cypionate Combination (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

IC B Complex Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

Tri-Mix Papaverine Injection (Talon) – Sterility Assurance Lack (2021)

Lack of assurance of sterility

Class IIModerate

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

TRI-MIX Papaverine (Talon Compounding) – Sterility Concern (2021)

Lack of assurance of sterility

Class IIModerate

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

Sermorelin Acetate/Ipamorelin (Talon) – Sterility Risk (2021)

Lack of assurance of sterility

Class IIModerate

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

Lidocaine Hydrochloride Topical Solution (Teligent) – Manufacturing Deviation (2021)

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 (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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