Recall: D-0583-2018

Class II - Potentially Harmful

Class IIClassification
2018-01-10Initiated
TerminatedStatus
Spirit Pharmaceuticals, LLCFirm

Product

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1

Reason

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

Distribution

NY

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.