January 2018 FDA Recall Valumeds Ibuprofen by Spirit Pharmaceuticals, Llc
D-0583-2018 - CGMP deviations
This Class II drug recall was voluntarily initiated by Spirit Pharmaceuticals, Llc on January 10, 2018 for the product Valumeds Ibuprofen. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NY and the recall is currently terminated.
Recall Number: D-0583-2018
CGMP deviations: Ibuprofen is being recalled in response to previous recall
01-10-2018
03-14-2018
144 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Spirit Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY
01-20-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
