Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

Class IHigh

FDAAug 3, 2023Nationwide• APG SEVEN, INC

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIILow

FDAJul 27, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Serious Brain Enhancer Capsules (Global Vitality) – E coli contamination (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Uro Kid Support Capsules (Global Vitality) – E. Coli Risk (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Tizanidine Hydrochloride Tablet 4mg (Preferred Pharmaceuticals) – Stability Failure (2023)

Failed Stability Specifications

Class IIModerate

FDAJun 26, 2023Nationwide• Preferred Pharmaceuticals, Inc.

PANCREAZE Digestive Enzyme Capsules (Vivus) – Stability Failure (2023)

Failed Stability Specifications

Class IIILow

FDAJun 23, 2023Nationwide• Vivus, Inc.

Diclofenac Sodium Topical Solution (Alembic) – Delivery System Defect (2023)

Defective Delivery System

Class IIModerate

FDAJun 22, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Tizanidine 4mg Tablets (Dr Reddy's) – Dissolution Specification (2023)

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Class IIModerate

FDAJun 21, 2023Nationwide• Dr Reddy's Laboratories Limited

Tranexamic Acid Tablets (AVKARE) – Conductivity Specification (2023)

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Class IIILow

FDAJun 13, 2023Nationwide• AVKARE LLC

1...41 424344 45...79

Page 43 of 79Next