FDA DrugsNot Yet Classified
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per ...
Published: July 8, 2026Recall ID: N/ACategory: drugsCountry: US
Reason for Recall / Hazard
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Naples |
| State | FL |
| Openfda › Upc | 0370748311011 |
| Openfda › Rxcui | 310497 |
| Openfda › Spl id | 8acd9382-8718-476e-a625-799607cf84d3 |
| Openfda › Brand name | GLUCAGON |
| Openfda › Spl set id | 3d8c92cf-9263-4126-8a5b-4cd761e31bc1 |
| Openfda › Package ndc › 1 | 70748-311-01 |
| Openfda › Package ndc › 2 | 70748-309-01 |
| Openfda › Package ndc › 3 | 70748-310-01 |
| Openfda › Product ndc | 70748-311 |
| Openfda › Generic name | GLUCAGON |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Manufacturer name | Lupin Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA214457 |
| Openfda › Is original packager | true |
| Event id | 99296 |
| Address 1 | 5801 Pelican Bay Blvd Ste 500 |
| Address 2 | N/A |
| 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. |
| Postal code | 34108-2734 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 64,894 units |
| Reason for recall | CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260623 |
| Initial firm notification |
Overview
- Recalling FirmLupin Pharmaceuticals Inc.
- StatusOngoing
- Risk LevelNot Yet Classified
- DistributionNationwide within the U.S.