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Class II · ModerateRecall completed

Ibuprofen

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) 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
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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMarksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India foreign manufacturer
Brand nameIBUPROFEN
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forTime Caps Labs, Farmingdale, NY
NDC49483-603-01
Show the full FDA record
Full product labelIbuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Recalling firmTime-Cap Laboratories, Inc.
DistributionNationwide.
QuantityN/A
Recall initiated2018-01-11
Report date2018-05-02
Recall completed2021-01-20
Recall numberD-0689-2018
ClassificationClass II
FDA statusTerminated
Origin on fileFarmingdale NY United States

Related

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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.