Nasal & Sinus Decongestant Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets 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 FDA classified this as Class II. The source text does not report any illnesses, injuries, or adverse events—only manufacturing practice deviations. Per the rubric, this is a moderate-severity voluntary precautionary recall with no reported harm.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant (phenylephrine HCl 5mg, 2 tablets per packet) manufactured for Cintas First Aid & Safety due to cGMP deviations. The affected product was distributed nationwide within the United States.
The recalled lots include: AK9491 and AK9496 (expiration date 02/2022), and K9817 (expiration date 09/2022). A total of 3,508,200 packets are subject to this recall.
The recall was initiated on January 24, 2022, and classified by the FDA as Class II on January 31, 2022. Consumers who have purchased this product should discontinue use and contact the recalling firm or consult their healthcare provider with questions.
The recalled product
- Product
- Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Oral decongestant
- Affected units
- 3,508,200
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 (5)
- Lot #: AK9491
- AK9496
- Exp. Date 02/2022
- K9817
- 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.
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