Cough & Cold Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.
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 is voluntary and precautionary in nature. No illnesses or injuries are reported in the source text, and the hazard (cGMP deviations) is cited without evidence of actual harm, placing this in the Moderate category per the rubric.
Plain-English summary
Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold Cough & Cold Relief (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) coated tablets, sold in 2-count packets and manufactured for HARTHealth in Seattle, WA.
The recall was initiated on January 24, 2022, due to current good manufacturing practice (cGMP) deviations discovered at the manufacturer. This is a voluntary, firm-initiated Class II recall. The affected lot number is AK9841 with an expiration date of October 2022.
The product was distributed nationwide within the United States. Consumers who have purchased this product should stop using it and consult with their healthcare provider if they have questions or concerns about their use of the affected batch.
The recalled product
- Product
- CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Manufacturer
- Ultra Seal Corporation
- Hazard
- Affected units
- 225,000
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 (2)
- Lot #: AK9841
- Ex. Date 10/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation 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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