ULTRAtab Laboratories recalls Legatrin (Acetaminophen 500mg, Diphenhydramine 50mcg) bulk containers due to CGMP deviations. Affected lots include 18K029, 18L059, etc. No remedy specified in recall notice.
CGMP Deviations
ULTRAtab Laboratories is recalling certain bulk containers of Legatrin (a combination pain and allergy medication) because of manufacturing quality control issues. This recall does not currently include a specific action for consumers since no remedy was stated in the official notice.
The recall is due to CGMP (Current Good Manufacturing Practice) deviations, which are regulatory standards for pharmaceutical quality. These deviations could potentially lead to unsafe medication production, though the specific nature of the deviation is not detailed in the recall notice.
This recall affects bulk containers of Legatrin sold by ULTRAtab Laboratories in the U.S. The most at-risk individuals are likely healthcare facilities or institutions that use these bulk containers for medication distribution.
Check for Legatrin bulk containers with NDC code 62959-785-00 and product codes M785L. Affected lots include 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, and 19J050.
Identify if your Legatrin bulk container has NDC 62959-785-00 and product code M785L with the listed affected lots.
The recall notice does not specify any remedy or action for consumers.
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) bulk containers with NDC 62959-785-00 and product codes M785L.
Affected lots include 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, and 19J050.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0552-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0552-2022 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.
