Prescription and over-the-counter medications
Novartis Pharmaceuticals
Failed Impurities/Degradation Specifications.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Supotent: Out of Specification result for assay test during routine stability testing.
Isomeric Pharmacy Solution
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Novartis Pharmaceuticals
Failed Impurities/Degradation Specifications.
Valeant Pharmaceuticals North America
Discoloration.
Subpotent
Subpotent
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Discoloration.
Qinhuangdao Zizhu Pharmaceutical
cGMP Deviations; lack of quality assurance.
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
Mckesson Medical Surgical
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.