Hetero USA Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0530-2023Class IIPantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for:March 14, 2023
D-1095-2017Class IIEntecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber PharmaceuticalJuly 20, 2017
D-0897-2017Class IIIAcyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals,April 27, 2017
D-0623-2017Class IIIMontelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber PharmaceuticalJanuary 7, 2017