SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.
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 voluntary recall for cGMP deviations with no reported illnesses or injuries. Per the rubric, Class II recalls without hospitalization or injury reports that are precautionary in nature are typically scored as Moderate (2).
Plain-English summary
Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets (containing acetaminophen 500 mg and Phenylephrine HCl 5.0 mg) in 2-tablet packet format nationwide. The recall was initiated on January 24, 2022, and involves approximately 122,400 packets (Lot #AK9766, Expiration Date 08/2022, NDC 69103-2536-00) manufactured for Tellus Medical Products, Palm Desert, California.
The recall was issued because the product does not meet current Good Manufacturing Practice (cGMP) standards. This is a voluntary recall initiated by the firm, with the FDA classifying it as Class II.
Consumers who have purchased SINU-PHEN PLUS sinus tablets from this lot should discontinue use and contact Ultra Seal Corporation or their retailer for guidance on return or disposal. The recall was terminated on October 16, 2023.
The recalled product
- Product
- SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Over-the-Counter Tablet
- Affected units
- 122,400
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 #: AK9766
- Exp. Date 08/2022
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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