Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
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 compliance issue. The source text does not report any illnesses, injuries, or hospitalization, making this a precautionary manufacturing-related recall that meets the Moderate severity threshold.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling PAINAID BRF Back Relief Formula, a pain relief medication containing acetaminophen 250 mg, caffeine 50 mg, and magnesium salicylate 290 mg in 2-tablet packets. The recall was initiated on January 24, 2022, due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing.
Approximately 111,300 packets of the product were distributed nationwide within the United States. The affected product is identified by Lot #AK9698 with an expiration date of 07/2022, and carries NDC 42961-0003-00. The product was distributed by ZEE Medical Distributors, LLC of Mason, Ohio.
Consumers who have purchased this product should stop using it. The FDA classified this as a Class II recall on January 31, 2022. The recall was terminated on October 16, 2023.
The recalled product
- Product
- PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Oral Pain Relief
- Hazard
- cgmp-deviation
- manufacturing-control
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 #: AK9698
- Exp. Date 07/2022
Distribution
Distributed nationwide across the United States.
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