D-0583-2018 Class II Terminated

Recalled by Spirit Pharmaceuticals, LLC — Ronkonkoma, NY

Recall Details

Product Type
Drugs
Report Date
March 14, 2018
Initiation Date
January 10, 2018
Termination Date
January 20, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
144 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

NY

Code Information

Lot#: HJ6138