KVK Tech recalls 75mg Indomethacin Extended-Release Capsules (NDC 10702-016-01) made in USA with cGMP deviations. Consumers should contact the manufacturer for details.
cGMP deviations
KVK Tech is recalling 75mg Indomethacin Extended-Release Capsules (100-count bottles) due to manufacturing deviations. This recall affects prescription-only medication made in the USA. The product may pose safety risks if the manufacturing issues lead to improper drug release.
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which are regulatory standards for drug production. These deviations could potentially affect the drug's release mechanism or safety profile, though the specific risk is not detailed in the recall notice.
Prescription holders of this medication are affected. Patients using the recalled product for conditions like arthritis or pain may be at risk if the manufacturing deviations impact drug effectiveness.
Check for the product name 'Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle' with NDC code 10702-016-01. The product was manufactured by KVK Tech in Newtown, PA, USA, with lot number 18400A and expiration date 7/31/2027.
Reach out to KVK Tech, Inc. for specific instructions on handling the recalled product.
The recall states there were cGMP deviations, but does not specify if the product is unsafe. Consumers should contact the manufacturer for details.
The product expires on July 31, 2027, as indicated in the recall notice.
Look for the NDC code 10702-016-01 on the product label. The product was manufactured by KVK Tech in Newtown, PA, USA.
We’ve drafted a message you can send KVK Tech to request your refund or repair — edit it as you like.
Subject: Recall D-0445-2025 — KVK Tech KVK Tech Hello, I own a KVK Tech that is covered by recall D-0445-2025 from KVK Tech. 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.