RemedyRepack Inc. recalls 5mg Rosuvastatin tablets due to cGMP deviations. Affected lots expire by 12/31/2023. Consumers should check product labels for specific lot numbers.
cGMP Deviations
RemedyRepack Inc. is recalling 5mg Rosuvastatin tablets that were repackaged by their company. The recall is due to cGMP deviations, which means the manufacturing process did not meet quality standards. This could affect the safety and effectiveness of the medication.
cGMP deviations refer to failures in the manufacturing process that could lead to unsafe or ineffective products. These deviations might affect the quality, safety, or potency of the medication, but the specific risks are not clearly stated in the recall notice.
People who have the 5mg Rosuvastatin tablets repackaged by RemedyRepack Inc. in the specified lot numbers are affected. Those with prescriptions for this medication are most at risk.
Check the product label for the lot number and expiration date. The affected lots include J0668398-121422 (expiring 12/31/2023), J0661225-111522 (expiring 11/30/2023), and J0646383-091422 (expiring 09/30/2023).
Look for the lot number and expiration date on the tablet packaging.
The recall is due to cGMP deviations, which means the manufacturing process did not meet quality standards. The specific risks are not clearly stated in the notice.
Check the product label for the lot numbers: J0668398-121422 (expiring 12/31/2023), J0661225-111522 (expiring 11/30/2023), or J0646383-091422 (expiring 09/30/2023).
The recall notice does not specify a remedy, so contact your healthcare provider for advice on next steps.
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0500-2023 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0500-2023 from RemedyRepack. 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.
