January 2016 FDA Recall Drug by Bonita Pharmaceuticals, Llc
D-0665-2016 - Marketed without an approved NDA/ANDA

This Class II drug recall was voluntarily initiated by Bonita Pharmaceuticals, Llc on January 27, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0665-2016

Reason for Recall
Marketed without an approved NDA/ANDA
Initiated
01-27-2016
Reported
02-24-2016
Quantity
3,308 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73174
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bonita Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-06-2019
Product Description About Product Description
Full technical description of the product.
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15

Batch or Lot Expiration Information

Lot# : 20150326, Exp 03/2018