Hetero USA Inc
Hetero USA Inc appears in FDA public data with 4 recalls, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0530-2023, Class II) was initiated on March 14, 2023.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0530-2023 | Class II | Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: | March 14, 2023 |
| D-1095-2017 | Class II | Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceutical | July 20, 2017 |
| D-0897-2017 | Class III | Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, | April 27, 2017 |
| D-0623-2017 | Class III | Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceutical | January 7, 2017 |