Direct Rx recalls 30-count Ropinirole 0.25mg tablets (NDC 72189-0364-30) due to cGMP deviations. Affected lots expire 7/31/23. No remedy provided in official notice.
cGMP deviations
Direct Rx is recalling 30-count Ropinirole 0.25mg tablets (NDC 72189-0364-30) because of manufacturing quality issues. This recall affects patients who have the specific lot numbers that expire by July 31, 2023.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which means the product was made under conditions that don't meet quality standards. This could potentially affect the safety and effectiveness of the medication, though the exact risk isn't specified in the recall notice.
Patients with a prescription for Direct Rx Ropinirole 0.25mg tablets (30-count bottle) that have the lot number 21JU2210 expiring July 31, 2023 are affected. Prescribers and pharmacies handling this specific product are also at risk.
Check for the 30-count bottle labeled 'Ropinirole, USP, 0.25 mg Tablets, Rx Only' with NDC 72189-0364-30. The lot number is 21JU2210 and expires July 31, 2023.
Verify the lot number and expiration date on the bottle to confirm if it matches 21JU2210 expiring July 31, 2023.
The official recall notice does not provide any remedy steps.
The affected lot number is 21JU2210, which expires July 31, 2023.
Check the lot number on the bottle; if it's 21JU2210 and expires July 31, 2023, it's affected.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0478-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0478-2023 from Direct Rx. 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.
