ULTRAtab Laboratories recalls Dologen 325 caplets due to CGMP deviations. Affected lots include NDC 62959-121-00, bulk lots 19G074 and 19G075. No specific remedy is stated in the recall notice.
CGMP Deviations
ULTRAtab Laboratories is recalling Dologen 325 caplets (acetaminophen 325 mg, dexbrompheniramine maleate 1.0 mg) that were produced with CGMP deviations. This recall is due to potential quality issues in manufacturing that could affect product safety.
CGMP deviations refer to failures in the manufacturing process that may result in unsafe products. These deviations could potentially affect the quality and safety of the medication, though the exact nature of the issue is not specified in the recall notice.
People who own or use Dologen 325 caplets with NDC 62959-121-00 and bulk lots 19G074 or 19G075 are affected. Those who have these specific products are most at risk.
Check for the product code C121L and NDC 62959-121-00 on the packaging. The affected bulk lots are 19G074 and 19G075.
Look for the NDC code 62959-121-00 and bulk lots 19G074 or 19G075 on the packaging.
The recall is due to CGMP deviations, which are manufacturing process failures 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 affected details.
Bulk lots 19G074 and 19G075 are affected.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0527-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0527-2022 from ULTRAtab Laboratories. 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.
