The Recall Desk
ModerateFDA (Drugs)·D-0476-2022·Announced 2022-02-09

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.

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 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
Hazard
  • cgmp-deviation
  • manufacturing-violation

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.

Related recalls

Same category