Ibuprofen Tablets USP recalled over manufacturing violations
- Recall date
- January 10, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Spirit Pharmaceuticals, LLC recalls Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779…
- Recall number
- D-0583-2018
- FDA classification
- Class II
- Brand / firm
- Spirit Pharmaceuticals, LLC
- Sold / distributed
- NY
Why it was recalled
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
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