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All product recalls associated with Hetero USA Inc.
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Mar 2023
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
CGMP Deviations: Discoloration
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.