FDA recall D-0695-2018

Product

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

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-0695-2018