FDAClass IIIJanuary 4, 2017

Techni-Care Surgical Hand Scrub and Patient recall: Labeling Error

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

Why was Techni-Care Surgical Hand Scrub and Patient recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Care-Tech Laboratories, Inc.
Quantity
106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.
Distribution
Nationwide
Recall date
January 4, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls