Cold Tablet with Acetaminophen Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets due to cGMP (current Good Manufacturing Practice) deviations. Approximately 313,000 packets of Lot #K9824 (Exp. Date 09/2022) distributed nationwide are affected.
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 text identifies this as an FDA Class II recall with cGMP deviations as the reason. No illnesses, injuries, or hospitalizations are reported in the source. cGMP deviations represent a manufacturing quality concern rather than a confirmed hazard, placing this in the Moderate category per the rubric.
Plain-English summary
Ultra Seal Corporation is conducting a voluntary, firm-initiated recall of Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant packets (acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg). The recall affects approximately 313,000 packets of Lot #K9824 with an expiration date of 09/2022, manufactured for Respond Industries and American First Aid in Mason, Ohio.
The FDA classified this as a Class II recall due to cGMP deviations identified in the manufacturing process. The recall was voluntarily initiated by the manufacturer on January 24, 2022, and classified by the FDA on January 31, 2022.
The affected product was distributed nationwide within the United States. Consumers who have purchased this product should discontinue use and may contact the recalling firm for further instructions regarding the recalled packets.
The recalled product
- Product
- Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Manufacturer
- Ultra Seal Corporation
- Hazard
- Affected units
- 313,000
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 (2)
- Lot #: K9824
- 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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