Class II · ModerateRecall completed
Ibuprofen Tablets USP 800 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18
Where it was soldNationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMarksans Pharma, Ltd., Verna, Goa-403 722, India foreign manufacturer
| Distributed by / for | Time-Cap Laboratories, Inc. |
| NDC | 42582-113-10 |
Show the full FDA record
| Full product label | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India |
| Recalling firm | Time-Cap Laboratories, Inc. |
| Distribution | Nationwide. |
| Quantity | N/A |
| Recall initiated | 2018-01-11 |
| Report date | 2018-05-02 |
| Recall completed | 2021-01-20 |
| Recall number | D-0693-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Farmingdale NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.