Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol...
FDA Recall #D-0235-2017 — Class III — November 8, 2016
Product Description
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
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.
Recalling Firm
Care-Tech Laboratories, Inc. — Saint Louis, MO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.
Distribution
Nationwide
Code 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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated