The Recall Desk
ModerateFDA (Drugs)·D-0481-2022·Announced 2022-02-09

Multi-Symptom Cramp Relief Drug Recalled for Manufacturing Deviations

Ultra Seal Corporation recalled 1,351,660 packets of Multi-Symptom Cramp Relief nationwide due to current good manufacturing practice (cGMP) deviations. The recall was voluntarily initiated and affects two lots with expiration dates in January and July 2022.

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 manufacturing deviations with no reported illnesses or injuries stated in the source text. The hazard is compliance-based rather than involving known contamination or imminent safety risk, making it a Moderate severity case per the rubric for FDA Class II recalls without reported harm.

Plain-English summary

Ultra Seal Corporation initiated a voluntary nationwide recall of Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg) in 2-tablet packets. The recall affects 1,351,660 packets manufactured for First Aid Direct in Mason, Ohio.

The recall was initiated due to current good manufacturing practice (cGMP) deviations. The affected lots are AK9453 (Expiration Date 01/2022) and AK9716 (Expiration Date 07/2022).

The product was distributed nationwide within the United States. Consumers should stop using affected packets and contact the manufacturer or healthcare provider with questions. This Class II recall was voluntarily initiated by the firm on January 24, 2022, and was terminated on October 16, 2023.

The recalled product

Product
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Pain/Cramp Relief
Hazard
Affected units
1,351,660

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 (4)

  • Lot #: AK9453
  • Exp. Date 01/2022
  • AK9716
  • 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 →

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