Hetero recalls
FDA enforcement reports naming Hetero USA Inc as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Apr 19, 2023
- Apr 19, 2023Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manu…Drug · Hetero USA IncCGMP Deviations: DiscolorationClass II
- Aug 23, 2017Entecavir Tablets 0Drug · Hetero USA IncFailed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.Class II
- Jun 14, 2017Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pha…Drug · Hetero USA IncPresence of Foreign Substance: human hair melded into tablet.Class III
- Apr 5, 2017Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber P…Drug · Hetero USA IncDiscoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.Class III