FDA recall D-0693-2018

Product

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, 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-0693-2018