Vintage Pharmaceuticals LLC, DBA Qualitest AMPICILLIN CAPSULES, USP, 250 mg, 500 count recall — FDA D-1350-2015
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Overview of recall records associated with Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals, including dates, categories and classifications where available.
Classification mix: Class III: 3, Class I: 2.
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
This page summarizes recall records in which the official source identifies Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.