Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0493-2022·Announced 2022-02-09

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units: 111,300

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.

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.

See all 56 products in this recall →

Same manufacturer · Ultra Seal Corporation

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