Why it was 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.
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0235-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 8, 2016
- FDA report date
- Jan 4, 2017
- Quantity
- 106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Care-Tech Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0235-2017, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 75535
- Address
- 3224 S Kingshighway Blvd
- 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
- Postal code
- 63139-1114
- Report date
- Jan 4, 2017
- Product type
- Drugs
- Recall number
- D-0235-2017
- Classification
- Class III
- Recalling firm
- Care-Tech Laboratories, Inc.
- Product quantity
- 106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.
- Termination date
- Dec 5, 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 8, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2016