Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations
Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.
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: This is an FDA Class II recall initiated voluntarily by the manufacturer due to cGMP deviations. The source text contains no reports of illness, injury, or hospitalization. The hazard is manufacturing process-related rather than an acute safety threat to consumers.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The product is manufactured for Afassco Inc. of Minden, Nevada, and is identified by NDC 51532-0107-2.
Approximately 225,350 packets of CHLORESIN have been distributed nationwide within the United States. The recall specifically affects Lot #AK9492 with an expiration date of 02/2022.
Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist with questions. The recall was initiated by the firm on January 24, 2022, and was classified by the FDA as Class II on January 31, 2022. The recall was terminated on October 16, 2023.
The recalled product
- Product
- CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Cold and Cough Medication
- Hazard
- manufacturing-deviation
- cgmp-violation
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 (2)
- Lot #: AK9492
- Exp. Date 02/2022
Distribution
Distributed nationwide across the United States.
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