FDA recall D-0304-2020

Product

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Distribution

Product was distributed to major distributors/wholesalers throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-11-01

Report date

2019-11-13

Termination date

2021-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2020