Direct Rx recalls 100mg Zonisamide capsules due to quality control gaps in microbiology testing. Affected lots from June 2023 expire June 30, 2023. No remedy specified in official notice.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Direct Rx is recalling 100mg Zonisamide capsules that were manufactured with quality control gaps in their microbiology testing. This recall affects specific lots that expire June 30, 2023, but no action is required as the official notice does not specify a remedy.
The recall is due to gaps in the quality control microbiology laboratory, which could potentially affect the safety and purity of the medication. However, the official notice does not specify the exact risk level or how this might impact patient safety.
Prescription patients who received Zonisamide capsules from Direct Rx in the US. Those with specific lot numbers (23JY2124) and expiration dates (June 30, 2023) are most at risk.
Check for the product name 'Zonisamide Capsules USP, 100 mg, 90-count bottle' with lot number 23JY2124 and expiration date June 30, 2023. The product was distributed by Direct Rx in Dawsonville, GA.
Verify the lot number (23JY2124) and expiration date (June 30, 2023) on the product label.
The official recall notice does not specify a remedy, so no action is required.
The expiration date is June 30, 2023.
Check for lot number 23JY2124 and expiration date June 30, 2023 on the product label.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0888-2022 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0888-2022 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.
