American Health Packaging Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit recall — FDA D-0854-2021
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Chemical Contamination: presence of benzene
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Subpotent Drug
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
cGMP Deviations
cGMP Deviations
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Defective container: Cracked vials leading to lack of sterility assurance
cGMP Deviations
Subpotent Drug
cGMP Deviations
Browse recent months with enough recall history for useful comparison.