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Lupin Pharmaceuticals Inc.: Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactu

DrugsSource: FDA (drug) · Date: 2026-07-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Lupin Pharmaceuticals Inc.
Product
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
Reason / hazard
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S.
Recall initiated
2026-06-23
Code info
Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.
Product quantity
64,894 units
Voluntary mandated
Voluntary: Firm initiated
City
Naples
State
FL
Country
United States
Event id
99296
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