Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations
Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.
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 for cGMP deviations, a manufacturing process issue. No illnesses, injuries, or deaths are reported in the source text, and the hazard is manufacturing-related rather than an imminent safety threat, making this a moderate-severity precautionary recall.
Plain-English summary
Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152 mg, caffeine 32.4 mg) nationwide within the United States. The recalled product consists of 2 tablets per packet, manufactured for Respond Industries and American First Aid, Mason, Ohio.
The recall was initiated on January 24, 2022, due to cGMP (current Good Manufacturing Practice) deviations. The firm voluntarily initiated this recall. The affected lot is #AK9493 with expiration date 02/2022.
Consumers who have purchased this product should stop using it. The FDA classified this recall as Class II on January 31, 2022. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 1,186,000
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 #: AK9493
- Exp. Date 02/2022
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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