Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01

Recall Number: D-0723-2026

Firm: Lupin Pharmaceuticals Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260708

Initiation Date: 20260623

Termination Date:

CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01