Pharma-Natural Recalls GENCONTUSS Cough Syrup Due to Manufacturing Violations
Pharma-Natural Inc. is recalling 3,000 bottles of GENCONTUSS cough syrup because it was manufactured with current good manufacturing practice violations.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, stemming from manufacturing process violations rather than a confirmed contamination or defect causing harm.
Plain-English summary
Pharma-Natural Inc. is recalling 3,000 bottles of GENCONTUSS (Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride) cough syrup. The product is a 16 fl oz (474 mL) cherry-flavored liquid manufactured in the USA for Kramer Novis. The recall covers all lots remaining within their expiration dates.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the products were manufactured with a lack of process validation, cleaning validation, and stability studies, along with other CGMP violations. These manufacturing deficiencies raise concerns about the product's quality and safety.
The affected product was distributed to consignees in Florida and Texas, who may have further distributed it nationwide in the USA and Puerto Rico. Consumers should check their medicine cabinets for GENCONTUSS with NDC 52083-650-16 and stop using it if found. They should contact their pharmacist or physician for guidance on alternative treatments.
The recalled product
- Product
- GENCONTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE)
- Brand
- GENCONTUSS
- Manufacturer
- Pharma-Natural Inc.
- Category
- Drug — OTC Cough & Cold
- Affected units
- 3,000
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)
- All lots remaining within expiry.
UPCs (1)
- 0352083650161
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pharma-Natural 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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