Drug Recall: Back Pain-Off Tablets Over cGMP Violations
Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.
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 involving cGMP deviations with no reported illnesses or injuries documented in the source text. The recall is voluntary and precautionary in nature, with the hazard being manufacturing-process violations rather than a direct safety incident.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets in 2-count packets. The recall was initiated on January 24, 2022, and classified by the FDA as Class II on January 31, 2022. The product was manufactured for MEDIQUE PRODUCTS in Fort Myers, Florida, with NDC 47682-073-00.
The recall is due to current good manufacturing practice (cGMP) deviations identified during manufacturing. Approximately 1,959,267 packets were distributed nationwide within the United States. The affected lots are: Lot #9708 (Exp. Date 07/2022), AK9810 (Exp. Date 09/2022), and AK9946/K9946 (Exp. Date 12/2022).
Consumers who have purchased this product should stop using it. Individuals with questions about this recall can contact the recalling firm, Ultra Seal Corporation, or consult with their healthcare provider. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Pain relief tablet
- Affected units
- 1,959,267
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 (7)
- Lot #: 9708
- Exp. Date 07/2022
- AK9810
- Exp. Date 09/2022
- AK9946
- K9946
- Exp. Date 12/2022
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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