Ultra Seal Corporation recalls Dolog: acetaminophen 325mg and dexbrompheniramine 1mg caplets in 90-count and 2-count packs due to cGMP deviations. No remedy specified.
cGMP deviations
Ultra Seal Corporation is recalling Dologen caplets (acetaminophen 325mg and dexbrompheniramine 1mg) in 90-count bottles and 2-count packets because of manufacturing quality control issues. This recall is due to deviations in current Good Manufacturing Practices (cGMP) that could affect product safety.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. These deviations could potentially lead to unsafe product quality, but the exact risk is not specified in the recall notice.
People who own or use Dologen caplets in 90-count bottles or 2-count packets with specific lot numbers and expiration dates are affected. Those with the product from the manufacturer in San Juan, Puerto Rico are at higher risk.
Check for Dologen caplets in 90-count bottles or 2-count packets with lot numbers 19G074 or 19G075 and expiration date 07/2022. The product was manufactured in San Juan, Puerto Rico for Kramer-Novis.
Identify if your Dologen caplets have lot numbers 19G074 or 19G075 and expiration date 07/2022.
The recall is due to cGMP deviations, which are quality control issues in manufacturing that could affect product safety.
The recall notice does not specify a remedy, so no action is required beyond checking if your product matches the recalled details.
Yes, the recalled product expires on 07/2022.
We’ve drafted a message you can send Ultra Seal Corporation to request your refund or repair — edit it as you like.
Subject: Recall D-0474-2022 — Ultra Seal Corporation Ultra Seal Corporation Hello, I own a Ultra Seal Corporation that is covered by recall D-0474-2022 from Ultra Seal Corporation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
