Cold Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.
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: This is an FDA Class II recall for cGMP deviations. The source text does not report any illnesses, injuries, or deaths. Manufacturing deviations are process-integrity issues rather than direct safety hazards with reported harm, placing this in the Moderate category per the rubric.
Plain-English summary
Ultra Seal Corporation is recalling Cold Relief Severe Pain/Cough tablets containing acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, and phenylephrine HCl 5mg. The product was distributed in 2-tablet packets and manufactured for Select Corporation in Carrollton, Texas.
The recall was initiated due to cGMP (current good manufacturing practice) deviations identified by the manufacturer. This is a voluntary recall initiated by the firm. The affected lot is #AK9436 with an expiration date of 01/2022. A total of 227,010 packets were distributed nationwide within the United States.
Consumers who have purchased this product should stop using it. Consult a healthcare provider if you have taken this medication and have health concerns. The FDA classified this as a Class II recall. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
- Manufacturer
- Ultra Seal Corporation
- Hazard
- manufacturing-deviation
- cgmp-violation
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 #: AK9436
- Exp. Date 01/2022
Distribution
Distributed nationwide across the United States.
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