The Recall Desk
ModerateFDA (Drugs)·D-0495-2022·Announced 2022-02-09

Drug Recall: CONGESTAID II Nasal Decongestant for Manufacturing Deviations

Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant packets due to current Good Manufacturing Practice (cGMP) deviations. The voluntary nationwide recall affects 447,050 packets.

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: FDA Class II recall with no reported illnesses or injuries mentioned in the source. The hazard is based on manufacturing process deviations without specific identified contamination, fitting the 'voluntary precautionary recalls' criterion.

Plain-English summary

Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2-tablet packets due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed by ZEE Medical Distributors, LLC and sold nationwide within the United States.

The recall was initiated due to cGMP deviations identified during manufacturing. The specific nature of these deviations is not detailed in the recall notice.

A total of 447,050 packets are affected. The recalled product includes Lot #AK9478 (expiration date 02/2022) and Lot #AK9799 (expiration date 09/2022). This recall was terminated on October 16, 2023.

Consumers who have purchased this product should stop using it. For further information or guidance on the recall, consumers may contact Ultra Seal Corporation or consult the FDA.

The recalled product

Product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Manufacturer
Ultra Seal Corporation
Category
Drug
Hazard
Affected units
447,050

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 #: AK9478
  • Exp. Date 02/2022
  • AK9799
  • Exp. Date 09/2022

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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