June 2012 FDA Recall Drug by Medtech Products, Inc. (D-1673-2012 - Subpotent (Single Ingredient) Drug)

This Class II drug recall was voluntarily initiated by Medtech Products, Inc. on June 20, 2012 for the product Drug. The FDA reported the reason for recall as subpotent (single ingredient) drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1673-2012

Reason for Recall
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Initiated
06-20-2012
Reported
09-12-2012
Quantity
12,720 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62402
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.
Medtech Products, Inc.
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.
04-11-2017
Product Description About Product Description
Full technical description of the product.
Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.

Batch or Lot Expiration Information

Lot# 11338, Exp 04/13