Valumeds Ibuprofen Tablet, Film Coated
FDA Recall NDC 68210-0800
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Valumeds Ibuprofen (NDC 68210-0800). A significant event, classified as Class II, was initiated on Jan 10, 2018 by Spirit Pharmaceuticals Llc. The reported reason for this action was: "CGMP deviations: Ibuprofen is being recalled in response to previous recall"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Jan 10, 2018
Mar 14, 2018
144 bottles
Recall Profile & Regulatory Data
Event ID
79361
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Spirit Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NY
Termination Date
Jan 20, 2021
Product Description
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Batch or Lot Expiration Information
Lot# : HJ6138
Affected Packages Involved in this Recall
68210-0800-1Product
68210-0800-4Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
