Cold/Sinus Medication Recalled for Manufacturing Process Violations
Ultra Seal Corporation is recalling 301,650 packets of a Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant due to cGMP deviations discovered during manufacturing. The product was 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 based on cGMP manufacturing deviations. The source text does not report any illnesses, injuries, or deaths, and the hazard is process-related rather than involving confirmed contamination or a known harmful condition. Class II recalls without reported harm typically fall into the Moderate category.
Plain-English summary
Ultra Seal Corporation is recalling Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant tablets (acetaminophen 325 mg, Phenylephrine HCl 5 mg) in packets of 2 tablets, manufactured for Respond Industries and American First Aid, Mason, OH. The recall involves Lot #K9708 with an expiration date of 07/2022, affecting 301,650 packets that were distributed nationwide within the United States.
The recall was initiated due to cGMP (Current Good Manufacturing Practice) deviations. This is a voluntary, firm-initiated recall that began on January 24, 2022, and was classified as Class II by the FDA on January 31, 2022. The recall was terminated on October 16, 2023.
Consumers who have this product should stop using it. Those with questions or concerns about this product should contact the manufacturer or their healthcare provider.
The recalled product
- Product
- Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cgmp-deviation
- manufacturing-defect
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 #: K9708
- Exp. Date 07/2022
Distribution
Distributed nationwide across the United States.
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