Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0486-2022·Announced 2022-02-09

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.

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: 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
Category: Drug — Over-the-Counter Medication
Hazard: cgmp-deviation
manufacturing-defect
Affected units: 301,650

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.

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.

See all 56 products in this recall →

Same manufacturer · Ultra Seal Corporation

See all →

Moderate
PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Exaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Cold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
Moderate
Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09

Same hazard · cgmp deviation