The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0467-2022·Announced 2022-02-09

Acetaminophen Pain Reliever Recalled for cGMP Deviations

Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was 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: The source classifies this as FDA Class II. The hazard is a manufacturing practice deviation without any reported illnesses, injuries, or deaths. The source text explicitly states the reason for recall is "cGMP deviations" with no indication of actual harm, making this a precautionary recall warranting a Moderate severity rating.

Plain-English summary

Ultra Seal Corporation is recalling approximately 1,236,000 packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) distributed nationwide in the United States. The affected product is the 2-tablet packet formulation manufactured for Advanced First Aid (Baltimore, MD) and American Safety & First Aid (Osceola, IN), with NDC 67060-210-68.

The recall was initiated due to current good manufacturing practice (cGMP) deviations identified at the manufacturing facility. The affected lots are AK9495 (expiration date 02/2022) and AK6413 (expiration date 05/2022).

This is a Class II recall initiated voluntarily by the firm on January 24, 2022. Consumers who have purchased this product should stop using it. The recall was terminated on October 16, 2023.

The recalled product

Product
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
Manufacturer
Ultra Seal Corporation
Category
Drug — Acetaminophen / Pain Reliever
Hazard
Affected units
1,236,000

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 #: AK9495
  • Exp. Date 02/2022
  • AK9613
  • Exp. Date 05/2022

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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