NDC 50436-0323

Ibuprofen 800 mg tablet, film coated

On the label: Unit Dose Services. It's a repackaged product: Unit Dose Services rebottles it from Time Cap Laboratories's NDC 49483-604.

Where the pills inside were made

Verna, India · makes it

Problems found, fixed voluntarily Last FDA inspection Apr 17, 2024. 6 inspections on record.

Jan 11, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lots: a) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18,
Jan 11, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lots: a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18
Jan 11, 2018 · Class II · Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lots: a) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114…
Jun 16, 2017 · Class II · Terminated
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Lots: Lot #: HN7003

Generic drug: Ibuprofen: see every company that makes it
Form: tablet, film coated
Strength: 800 mg
Approval: ANDA ANDA090796
On the market since: Dec 30, 2015
Package NDCs: 50436-0323-1 50436-0323-2 50436-0323-3
Official label: DailyMed (National Library of Medicine), updated Jun 28, 2023

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