Reported Mar 14, 2018 · Terminated

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY…

Spirit Pharmaceuticals, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spirit Pharmaceuticals, LLC · 2004 Orville Dr N Ste 2 · Ronkonkoma, NY · 11779-7645

Is this the product you have?

  • Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC
  • Distributed BySpirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Lot codes and dates
  • Lot#: HJ6138
Amount recalled
144 bottles

Where it was sold

Why it was recalled

CGMP deviations: Ibuprofen is being recalled in response to previous recall

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 20, 2021 · Data as of Sep 19, 7:16 PM UTC

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