FDA Import Refusal AEK-7542467-9/40002/1 — Alkem Laboratories Ltd

Alkem Laboratories Ltd — FEI 3006585372

The FDA refused shipment AEK-7542467-9/40002/1 from Alkem Laboratories Ltd (India) on Sep 5, 2025. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Sep 5, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
56BCC03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.