FDA Import Refusal AEK-0997703-3/20002/1 — Hetero Labs Limited (Unit-11)

Hetero Labs Limited (Unit-11) — FEI 3009471127

The FDA refused shipment AEK-0997703-3/20002/1 from Hetero Labs Limited (Unit-11) (India) on Aug 31, 2026. The refused product falls under Drugs and Biologics — VONOPRAZAN (ANTI-SECRETORY). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Aug 31, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
62TDY10 VONOPRAZAN (ANTI-SECRETORY)
Charges
75