Drug 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
D-0235-2017
Product summary
- Event
- Event 75535
- Status
- Terminated
- Classification
- Class III
- Quantity
- 106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.
- Official record key
drug-enforcement:D-0235-2017
Official wording
Reason: 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.
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
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing