Entecavir Tablets 0.5 mg, 30 tablets per container recall — FDA D-1095-2017
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Overview of recall records associated with Hetero USA Inc., including dates, categories and classifications where available.
Classification mix: Class III: 2, Class II: 1.
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Presence of Foreign Substance: human hair melded into tablet.
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
This page summarizes recall records in which the official source identifies Hetero USA Inc. 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.