Glucagon Emergency Kit for Low Blood Sugar
cGMP deviations: Temperature abuse
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Glucagon
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Glucagon NDC 70748-0311 |
Kit | Lupin Pharmaceuticals, Inc. | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Defective delivery system: detached needles on the syringe in the kit.
Failed content uniformity specifications.
Presence of Foreign Substance
Presence of particulate matter: a white thread-like structure in the cartridge
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
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