Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.
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 for cGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations, indicating the hazard is non-acute. Under the severity rubric, Class II recalls without reported harm typically score 2 (Moderate).
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) in 2-tablet packets, manufactured for Select Corporation in Carrollton, TX. The recall affects 227,010 packets distributed nationwide within the United States. Lot #AK9436 with expiration date 01/2022 is included in this recall.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. The firm notified the FDA by letter, and the recall was classified as FDA Class II on January 31, 2022. The recall was terminated on October 16, 2023.
Consumers who have purchased this product should stop using it. The source text does not specify consumer return procedures or compensation details. Consumers with questions may contact the recalling firm or the FDA.
The recalled product
- Product
- Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 227,010
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 #: AK9436
- Exp. Date 01/2022
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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