FDA Recalls Humatrix Microclysmic Gel for Manufacturing Practice Violations
Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel nationwide due to deviations from proper manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 for manufacturing practice deviations without reported illnesses, injuries, or specific contamination identified in the source. The precautionary nature and absence of reported consumer harm support a Moderate classification.
Plain-English summary
Consolidated Chemical, Inc. is recalling 3186 bottles of Humatrix Microclysmic Gel, 8 oz per bottle, distributed nationwide in the United States. The affected product includes Lot 3216 (expiring April 2023) and Lot 3218 (expiring October 2023).
The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMP). The company identified violations in its manufacturing processes that did not meet regulatory standards.
The recalled product
- Product
- Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
- Manufacturer
- Consolidated Chemical, Inc
- Category
- Drug
- Hazard
- Affected units
- 3,186
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 (4)
- Lot
- expiry: Lot 3216
- exp 04/23 and 3218
- exp 10/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Consolidated Chemical, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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