Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
5 FDA recalls mention Valproic. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Valproic.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Reason Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Reason Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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