Care-Tech Recalls Surgical Hand Scrub Due to Labeling and Cap Defects
Care-Tech Laboratories is recalling Techni-Care Surgical Hand Scrub because bottles have missing or illegible lot and expiration dates, as well as defective or cracked caps.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issues are limited to labeling errors and packaging defects.
Plain-English summary
Care-Tech Laboratories, Inc. is voluntarily recalling Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol). The recall involves 106,506 bottles in various sizes, including 4 oz, 8 oz, 16 oz, 12 oz pumpettes, and 32 oz bottles. The product is distributed nationwide.
The recall was initiated because the product is missing or has illegible lot and expiration codes. Additionally, some bottles have defective or cracked caps. The affected lot numbers and expiration dates are listed in the structured product information.
Consumers and healthcare facilities should stop using the recalled product and contact Care-Tech Laboratories for a refund or replacement. The FDA classifies this as a Class III recall, indicating that the product is unlikely to cause adverse health consequences.
The recalled product
- 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…
- Manufacturer
- Care-Tech Laboratories, Inc.
- Category
- Drug — Topical Antiseptic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distributed nationwide across the United States.
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