Drug product
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
D-0541-2026
Product summary
- Event
- Event 98809
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 217,621 pen injectors
- Official record key
drug-enforcement:D-0541-2026
Official wording
Reason: Presence of particulate matter: a white thread-like structure in the cartridge
Code information: Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027.
Distribution pattern: Nationwide within U.S
Derived failure modes
-
Foreign material or chemical contamination
particulate matter