NDC 72189-324
Ibuprofen 400 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Time Cap Laboratories's NDC 49483-602.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Marksans Pharma Limited | Verna, India | Makes it | Problems found, fixed voluntarilyApr 17, 2024 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Jan 11, 2018 · Class II · Time-Cap Laboratories, Inc.
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 · Time-Cap Laboratories, Inc.
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 · Time-Cap Laboratories, Inc.
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 · Time-Cap Laboratories, Inc.
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Lots: Lot #: HN7003
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ibuprofen: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA090796
- On the market since
- Feb 21, 2022
- Package NDCs
72189-324-3072189-324-60- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
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