ABC Compounding Recalls Surgent Antiseptic Hand Soap Due to CGMP Deviations
ABC Compounding Co., Inc. is voluntarily recalling 576 bottles of Surgent Antiseptic Hand Soap due to Current Good Manufacturing Practice (CGMP) deviations.
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: The recall is classified as Class II due to CGMP deviations. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
ABC Compounding Co., Inc. is voluntarily recalling 576 bottles of SunCoast Paper Inc. Surgent Antiseptic Hand Soap, 1 Gallon (3.8 L). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations.
The affected product is identified by UPC 654441P10219. The source indicates that 2,256 bottles were involved in the distribution, with the recall covering 576 bottles. The product was distributed nationwide in the United States.
Consumers should stop using the product and contact the recalling firm for instructions on return or disposal. The recall status is ongoing.
The recalled product
- Product
- SunCoast Paper Inc. Surgent Antiseptic Hand Soap, Net Contents : 1 Gallon (3.8 L), SunCoast Paper In., 4111 Community Rd., Brunswick, GA 31520, UPC 654441P10219
- Manufacturer
- ABC Compounding Co., Inc.
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 576
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 (1)
- 2256 bottles
Distribution
Distributed nationwide across the United States.
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