November 2016 FDA Recall Drug by Care-tech Laboratories, Inc.
D-0235-2017 - Labeling

This Class III drug recall was voluntarily initiated by Care-tech Laboratories, Inc. on November 8, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0235-2017

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Initiated
11-08-2016
Reported
01-04-2017
Quantity
106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Care-Tech Laboratories, 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.
12-05-2017
Product Description About Product Description
Full technical description of the product.
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139

Batch or Lot Expiration Information

Lot# a) 3181, 3183, 3183A, exp. 11/16; b) 3184, 3184A, exp. 12/16; c) 3188, 3188A, exp. 11/17; d) 3191, exp. 6/18; e) 3192B, 3192C, exp. 7/18