New GPC Inc. Recalls Ferrol Expectorant for Labeling Deficiencies
New GPC Inc. is recalling Ferrol Expectorant because the product lacks required OTC drug listings and 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 due to labeling and listing deficiencies rather than a direct physical hazard or reported illness, fitting the criteria for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
New GPC Inc. has initiated a recall of Ferrol Expectorant, a 100 mL over-the-counter drug product. The recall involves 36 units of the product, which is packaged in a plastic bottle within a small blue carton. The product was manufactured in Guyana and distributed in New York.
The recall was issued because the product does not meet monograph requirements. Specifically, the product lacks a required drug listing, fails to meet OTC drug labeling requirements, and is labeled as "Not Approved for sale in U.S.A." The specific batch number associated with this recall is 305206.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
- Manufacturer
- New Gpc Inc.
- Category
- Drug — Over-the-Counter (OTC)
- Affected units
- 36
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)
- Batch Numbers: 305206
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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