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 #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, Exp 04/18; HN6024, Exp 07/18; HN6025, HN6026, HN6027, Exp 09/18
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
- 600 mg
- Approval
- ANDA ANDA090796
- On the market since
- Feb 28, 2011
- Package NDCs
25000-122-0325000-122-12- Official label
- DailyMed (National Library of Medicine), updated Aug 28, 2024
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