Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.
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 recall is classified as FDA Class II and is voluntary and precautionary in nature. No illnesses, injuries, or deaths are reported in the source text. The hazard stems from manufacturing process deviations rather than confirmed product contamination or defect.
Plain-English summary
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets due to cGMP deviations. The product was manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico, and is sold in 90-count bottles and 2-count packets under NDC 52083-482-02.
Affected lots are 19G074 and 19G075 with an expiration date of 07/2022. In total, approximately 9,060 bottles and 44,700 packets have been distributed nationwide within the United States.
Consumers in possession of this product should stop using it. The recall was voluntarily initiated by the firm and has been classified as a Class II recall by the FDA. Additional information is available from the FDA's drug recall website.
The recalled product
- Product
- Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
- Manufacturer
- Ultra Seal Corporation
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 (4)
- Lot #: a) 19G074
- 19G075
- Exp. Date 07/2022
- b) 19G075
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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