FDA recall D-0689-2018

Product

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate 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-0689-2018