FDA-Drug2019-01-16Class II
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Hazard
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Sold states
Nationwide within the United States
Affected count
287,784 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0376-2019More Lupin Pharmaceuticals Inc. recalls
- FDA-Drug2026-07-08prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
- FDA-Drug2026-07-08Glucagon 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
- FDA-Drug2026-05-27Lupin Liraglutide Injection recalled for particulate matter in cartridges
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