FDA recall D-0583-2018

Product

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1

Reason for recall

CGMP deviations: Ibuprofen is being recalled in response to previous recall

Distribution

NY

Key facts

Status

Terminated

Initiation date

2018-01-10

Report date

2018-03-14

Termination date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ronkonkoma, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0583-2018