Pain & Sinus Reliever tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling 887,000 packets of Pain & Sinus Reliever (acetaminophen/phenylephrine) tablets nationwide due to cGMP manufacturing deviations. The recalled product is identified by Lot #AK9527 with expiration date 03/2022.
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: The recall is FDA Class II with no reported illnesses or injuries. The hazard is a manufacturing practice deviation rather than a direct contamination or defect with known harm. This qualifies as a moderate-severity precautionary recall.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling 887,000 packets of Pain & Sinus Reliever Pain Reliever/Nasal Decongestant tablets containing acetaminophen 500mg and Phenylephrine HCl 5mg. The product was manufactured for Advanced First Aid in Baltimore, MD (NDC 67060-194-68).
The recall was initiated on January 24, 2022, due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The affected lot is #AK9527 with an expiration date of March 2022.
The recalled product was distributed nationwide within the United States. Consumers who have purchased this product should stop use and contact their healthcare provider or pharmacist with any questions about whether they may have been affected.
The recalled product
- Product
- Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 887,000
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 #: AK9527
- Exp. Date 03/2022
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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