FDA recall D-0380-2019

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

Reason for recall

CGMP Deviation; manufacturing batch record could not be located

Distribution

Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-01-07

Report date

2019-01-23

Termination date

2020-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0380-2019