FDA recalls Techni-Care Chloroxylenol antiseptic due to manufacturing deviations
Consolidated Chemical is recalling Techni-Care Chloroxylenol 3% in 4 oz and 8 oz bottles nationwide due to manufacturing practice violations. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is based on manufacturing practice deviations without specification of a particular safety hazard, qualifying this as a precautionary manufacturing-related recall.
Plain-English summary
Consolidated Chemical, Inc. is recalling Techni-Care Chloroxylenol 3% solution in 4 fluid ounce and 8 fluid ounce bottles. The recall affects approximately 6,580 units of the 4 oz size and 1,248 units of the 8 oz size distributed nationwide in the United States.
The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) standards during manufacturing. No specific illnesses or injuries have been reported in connection with this product.
Affected product codes are Lot 3217A and Lot 3217B with expiration dates in June 2023 (NDC 46706-222-01 for 4 oz bottles and NDC 46706-222-02 for 8 oz bottles). Consumers who have purchased this product should stop using it and contact Consolidated Chemical, Inc. or their healthcare provider with questions.
The recalled product
- Product
- Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02
- Manufacturer
- Consolidated Chemical, Inc
- Category
- Drug — Topical antiseptic
- Hazard
- cgmp-deviation
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 (2)
- Lots 3217A and 3217B
- exp 06/23
Distribution
Distributed nationwide across the United States.
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