14,806 recalls, newest first
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Failed Stability Specifications
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.
cGMP Deviations; lack of quality assurance.