Drug 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
N/A
Product summary
- Event
- Event 99296
- Status
- Ongoing
- Classification
- Not Yet Classified
- Quantity
- 64,894 units
- Official record key
drug-enforcement:N/A
Official wording
Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Code information: 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.
Distribution pattern: Nationwide within the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP deviation