RemedyRepack Inc. recalls 30-count Rosuvastatin 5mg tablets (Rx only) due to cGMP deviations. Affected lots expire by Dec 2023. Consumers should check labels for specific lot numbers.
cGMP Deviations
RemedyRepack Inc. is recalling 30-count Rosuvastatin 5mg tablets (prescription-only) because of manufacturing quality control issues. This recall affects specific batches that expired by December 2023. The issue could lead to unsafe drug quality, but no injuries have been reported.
The recall is due to cGMP (current Good Manufacturing Practice) deviations during repackaging. This means the tablets may not meet safety and quality standards, potentially causing inconsistent drug strength or contamination. However, no injuries have been reported from this specific issue.
Prescription holders of Rosuvastatin 5mg tablets from RemedyRepack Inc. in Indiana, PA. People with high cholesterol who require this medication are most at risk if they use the recalled batches.
Check your Rosuvastatin 5mg tablets for the lot numbers: J0668398-121422 (expires Dec 2023), J0661225-111522 (expires Nov 2023), or J0654053-101822 (expires Sep 2023).
Look for the lot numbers listed above on the tablet packaging to confirm if your product is affected.
RemedyRepack Inc. recalled these tablets due to cGMP deviations during repackaging, which could affect drug quality but no injuries have been reported.
Check the lot numbers on the label: J0668398-121422 (expires Dec 2023), J0661225-111522 (expires Nov 2023), or J0654053-101822 (expires Sep 2023).
The recall does not require immediate action; check the label and contact your doctor if you have concerns about your medication.
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0495-2023 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0495-2023 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.
