ULTRAtab Laboratories recalls acetaminophen 500mg bulk containers due to CGMP deviations. Affected lots from 18M043 to 19F010. No specific remedy stated in official notice.
CGMP Deviations
ULTRAtab Laboratories is recalling acetaminophen 500mg bulk containers that were made between specific dates. This recall is due to manufacturing process deviations that could affect product safety.
CGMP deviations mean the manufacturing process did not meet quality standards. This could lead to inconsistent product quality, but the official notice does not specify how this affects safety or health.
Healthcare facilities and pharmacies that use this bulk container for dispensing acetaminophen. Staff handling these products are most at risk due to potential quality issues.
Check for product codes L211L and bulk lots 18M043 through 19F010. The container is labeled as 'APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container' from ULTRAtab Laboratories in Highland, NY.
Identify if your container has product code L211L and bulk lots 18M043 to 19F010.
The recall is due to CGMP deviations in manufacturing, which means the product did not meet quality standards. The official notice does not specify the exact safety risk.
The official notice does not state a specific remedy, so no action is required beyond checking if your product is affected.
The official notice does not describe a specific hazard that could cause injury, so the risk is unknown.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0537-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0537-2022 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.
