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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 numberLot #: HN7003
Where it was soldNationwide U.S.A.
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

Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.

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 Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA
NDC49483-603-50
Show the full FDA record
Full product labelIbuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
Recalling firmTime-Cap Laboratories, Inc.
DistributionNationwide U.S.A.
Quantity1,980 bottles
Recall initiated2017-06-16
Report date2017-08-09
Recall completed2020-05-29
Recall numberD-1055-2017
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.