Glucagon Emergency Kit Recalled for Manufacturing Process Deviation
Lupin Pharmaceuticals is recalling Glucagon Emergency Kits (1mg) nationwide due to a manufacturing process deviation found during stability testing. The gliding force functionality test failed to meet specifications during 12-month testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a critical emergency medication where a manufacturing process deviation has resulted in out-of-specification functionality test results. The product's failure to meet specifications in a life-sustaining device (emergency glucagon kit) for treating severe hypoglycemia constitutes a serious health risk, meeting the criteria for Severe severity.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection USP, 1mg per vial) distributed nationwide in the United States. The recall affects 64,894 units sold under NDC 70748-311-01.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation identified during product stability testing. During 12-month long-term stability testing, the gliding force functionality test produced out-of-specification (OOS) results, indicating the product may not perform as intended.
Affected lots include: WB00010 (expiration date January 2027), WB00017, WB00019 (expiration date February 2027), WB00070 (expiration date June 2027), WB00077, WB00078 (expiration date July 2027), and WB00130 (expiration date November 2027).
Patients and healthcare providers with these kits should contact Lupin Pharmaceuticals Inc. or consult their healthcare provider regarding appropriate replacement or continued use options.
The recalled product
- Product
- GLUCAGON (GLUCAGON)
- Brand
- GLUCAGON
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Emergency Medication
- Hazard
- cgmp-deviation
- out-of-specification
- product-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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.
UPCs (1)
- 0370748311011
Distribution
Distributed nationwide across the United States.
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