ULTRAtab recalls bulk APAP 325 mg/Phenylephrine HCl tablets due to CGMP deviations. Affected lots from Highland, NY NDC 62959-135-00. No remedy specified in official notice.
CGMP Deviations
ULTRAtab is recalling a bulk container of APAP 325 mg/Phenylephrine HCl tablets (NDC 62959-135-00) because of manufacturing quality control issues. This recall does not include retail products but affects bulk lots sold to pharmacies or distributors.
CGMP deviations refer to failures in the manufacturing process that could affect product safety and quality. Without specific details on the nature of the deviations, the exact hazard cannot be determined.
Pharmacies and distributors that received the bulk container with lot number 19F077 from ULTRAtab Laboratories, Inc. in Highland, NY are most at risk.
Check for the product code C135LA and bulk lot number 19F077 on the container. The product was sold by ULTRAtab Laboratories, Inc. in Highland, NY.
Verify the product code C135LA and bulk lot number 19F077 on the container.
No, this is a bulk container for pharmacies and distributors, not retail products.
The official recall notice does not specify any remedy or action steps.
The recall is due to CGMP deviations, which are manufacturing quality control issues that may affect product safety.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0529-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0529-2022 from ULTRAtab. 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.
