Sinus Relief Drug Recall for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).
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 drug recall for manufacturing deviations. The source text does not report any illnesses, injuries, or hospitalization cases; the hazard is regulatory compliance-related rather than an immediate safety threat with documented harm.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Sinus Relief tablets containing acetaminophen 325mg, Guaifenesin 200mg, and phenylephrine HCl 5mg sold in 2-tablet packets. The recall affects approximately 447,190 packets manufactured for Select Corporation and distributed nationwide within the United States.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The affected lots are AK9651 with an expiration date of 06/2022 and AK9437 with an expiration date of 01/2022.
Consumers who have purchased this product should stop use immediately. The recall was initiated on January 24, 2022, and was terminated on October 16, 2023.
The recalled product
- Product
- Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cgmp-deviation
- manufacturing-compliance
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 (4)
- Lot #: AK9651
- Exp. Date 06/2022
- AK9437
- Exp. Date 01/2022
Distribution
Distributed nationwide across the United States.
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