New GPC Inc. Recalls Alcosulph Astringent Lotion for Labeling Deficiencies
New GPC Inc. is recalling Alcosulph Astringent Lotion because it lacks required drug listings and OTC labeling, and is labeled as not approved for sale in the U.S.
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 FDA Class II and involves labeling and regulatory compliance issues (lack of listing/approval) rather than a direct physical hazard like contamination or injury, fitting the Moderate severity criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
New GPC Inc. has initiated a recall of Alcosulph Astringent Lotion, available in 60 mL and 120 mL glass containers. The product is packaged in small cartons and originates from Guyana. The recall involves 900 units distributed in New York, specifically batch numbers 304159, 211463, and 308345.
The recall was issued because the product does not meet monograph requirements. Specifically, the product lacks a drug listing, fails to meet Over-the-Counter (OTC) drug labeling requirements, and is labeled as "Not Approved for sale in U.S.A." This indicates the product was not legally authorized for distribution in the United States.
Consumers who have purchased this product should stop using it and contact New GPC Inc. for further instructions or a refund. The product should be kept away from children and pets until it can be properly disposed of or returned.
The recalled product
- Product
- alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.
- Manufacturer
- New Gpc Inc.
- Category
- Drug — Over-the-Counter (OTC)
- Affected units
- 900
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 (3)
- Batch Numbers: 304159
- 211463
- 308345
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by New Gpc 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.
See all 7 products in this recall →Related recalls
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