FDAClass IIMarch 14, 2018

Ibuprofen Tablets USP recall: CGMP Deviations

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

Why was Ibuprofen Tablets USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: HJ6138

Product
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Recalling firm
Spirit Pharmaceuticals, LLC
Quantity
144 bottles
Distribution
NY
Recall date
March 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls