Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations
Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 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 manufacturer due to cGMP deviations. The source text contains no reports of illness, injury, or hospitalization. The hazard is manufacturing process-related rather than an acute safety threat to consumers.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The product is manufactured for Afassco Inc. of Minden, Nevada, and is identified by NDC 51532-0107-2.
Approximately 225,350 packets of CHLORESIN have been distributed nationwide within the United States. The recall specifically affects Lot #AK9492 with an expiration date of 02/2022.
Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist with questions. The recall was initiated by the firm on January 24, 2022, and was classified by the FDA as Class II on January 31, 2022. The recall was terminated on October 16, 2023.
The recalled product
- Product
- CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Cold and Cough Medication
- Affected units
- 225,350
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 #: AK9492
- 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.
See all 56 products in this recall →Related recalls
Same manufacturer · Ultra Seal Corporation
See all →- ModeratePEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateCold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateLite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExtra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
Similar recalls
- ModerateCold Tabs Drug Recalled for CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16
- Moderate3-Component Cold Tabs Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModeratePharma-Natural Recalls Tusslin Cough Syrup Due to Manufacturing Violations
FDA (Drugs) · 2019-07-31
- ModerateDrug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations
FDA (Drugs) · 2022-02-16
- HighChildren's Cough Medicine Recalled for Manufacturing Control Deficiency
FDA (Drugs) · 2022-09-14
- ModerateZee Cold Tabs Recalled for CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16