Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, In
Recalled January 23, 2019 · FDA recall D-0380-2019 · Lupin Pharmaceuticals
Hazard
CGMP Deviation; manufacturing batch record could not be located · FDA Class II
Units
7,215 bottles
Sold at
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Description
CGMP Deviation; manufacturing batch record could not be located
Product
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →