Cold Terminator decongestant recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 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: This is an FDA Class II recall initiated voluntarily by the firm for cGMP deviations. The source text does not report any illnesses, injuries, or adverse events associated with the product, and the hazard is manufacturing-process related rather than a direct safety threat. Per the rubric, voluntary precautionary recalls without reported harm typically score 2.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets (containing acetaminophen 325 mg, Guaifenesin 200 mg, and Phenylephrine HCl 5.0 mg) in 2-tablet packets. The product is manufactured for Tellus Medical Products, Carlsbad, CA 92011, and carries NDC 69103-2556.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified during manufacturing. The recalled lot is Lot #AK9587 with an expiration date of 02/2022. A total of 226,400 packets have been distributed nationwide within the United States.
Consumers who have purchased this product should stop use and consult their healthcare provider or pharmacist if they have any concerns. The recall was initiated on January 24, 2022, classified as FDA Class II, and was terminated on October 16, 2023.
The recalled product
- Product
- COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-2556
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 226,400
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 #: AK9587
- Exp. Date 02/2022
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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