Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Marksans Pharma Limited | Verna, India | Makes it | Problems found, fixed voluntarilyApr 17, 2024 · 6 inspections |
Recalls
- Jan 9, 2018 · Class II · Marksans Pharma Inc.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Lots: Lot #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, HM6096, Exp 02/18; HM6097, HM6098, HM6099, Exp 03/18;…
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, oral
- Strength
- 800 mg
- Approval
- ANDA ANDA090796
- On the market since
- Feb 28, 2011
- Package NDCs
25000-123-0325000-123-12- Official label
- DailyMed (National Library of Medicine), updated Aug 28, 2024
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