FDA recall D-0686-2018

Product

Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2018-01-11

Report date

2018-05-02

Termination date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Farmingdale, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0686-2018