FDA-Drug2019-02-06Class II
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Hazard
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Sold states
Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
Affected count
14,400 bottles
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2019More 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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