Regular Strength Pain Reliever recalled for cGMP deviations
Ultra Seal Corporation is recalling approximately 1.18 million packets of Regular Strength Pain Reliever nationwide due to current good manufacturing practice (cGMP) deviations.
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 recall initiated voluntarily by the firm for cGMP deviations. The source text does not report any illnesses, injuries, or hospitalizations related to the product. The hazard is a manufacturing process deviation without confirmed product harm, which qualifies as a moderate-severity precautionary recall.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling approximately 1,180,000 packets of Regular Strength Pain Reliever containing acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4 mg, and salicylamide 152 mg. The product was manufactured for Advanced First Aid in Baltimore, Maryland (NDC 67060-0113-00). The recall affects lot #AK9450 with expiration date 01/2022.
The product is being recalled due to current good manufacturing practice (cGMP) deviations. The FDA classified this as a Class II recall on January 31, 2022, and the recalling firm initiated the recall on January 24, 2022.
The affected product was distributed nationwide within the United States. Consumers who have purchased this product should stop using it. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cGMP-deviation
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 #: AK9450
- Exp. Date 01/2022
Distribution
Distributed nationwide across the United States.
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