The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0478-2022·Announced 2022-02-09

Multi Symptom Cold Relief tablets recalled for cGMP deviations

Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) deviations.

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 initiated voluntarily for cGMP deviations. The source text contains no reports of actual illness, injury, or harm. Under the rubric, manufacturing deviations without reported adverse effects are classified as Moderate (score 2).

Plain-English summary

Ultra Seal Corporation is voluntarily recalling Multi Symptom Cold Relief tablets (containing acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, and Phenylephrine HCl 5 mg) sold in 2-count packets and distributed by Honeywell Safety Products USA of Smithfield, Rhode Island. The recall affects 673,160 packets distributed nationwide within the United States.

The recall was initiated due to cGMP deviations discovered in the manufacturing process. The affected products are identified by Lot #AK9715 and K9715, with an expiration date of 07/2022.

Consumers who have purchased this product should stop using it. The recall was voluntarily initiated by the firm on January 24, 2022, and was classified as FDA Class II by the agency on January 31, 2022. The recall was terminated on October 16, 2023.

The recalled product

Product
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Manufacturer
Ultra Seal Corporation
Category
Drug
Hazard
Affected units
673,160

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 (3)

  • Lot #: AK9715
  • K9715
  • 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 →

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