Prescription and over-the-counter medications
Olympia Compounding Pharmacy
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
cGMP Deviations
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Mylan Pharmaceuticals
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Preferred Pharmaceuticals
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
North American Custom Laboratories, LLC
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
VIRGIN SCENT
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Preferred Pharmaceuticals
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Teva Pharmaceuticals USA
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.
Preferred Pharmaceuticals
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.