Sun Pharmaceutical recalls Cinacalcet 60mg tablets due to microbial contamination in manufacturing equipment. This recall affects specific lots and requires immediate action to prevent potential health risks.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sun Pharmaceutical is recalling Cinacalcet 60mg tablets that may have microbial contamination from manufacturing equipment. This could pose a health risk if the tablets are taken without proper cleaning.
Microbial contamination occurred in stagnant water within the manufacturing equipment's duct. This could lead to harmful bacteria entering the tablets during production, potentially causing infections if consumed.
Prescription patients who have received the recalled lot of Cinacalcet tablets. Those with kidney disease or on calcium-regulating treatments are at higher risk.
Check for the lot number DNE0702A on the packaging. The product was distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ, and manufactured in India with an expiration date of 06/30/2026.
Look for the lot number DNE0702A on the packaging to confirm if your tablets are affected.
Microbial contamination was reported in stagnant water in the manufacturing equipment's duct, which could lead to harmful bacteria in the tablets.
The recall record does not specify a remedy, so contact Sun Pharmaceutical directly for guidance.
The recall indicates a potential health risk from microbial contamination, but the exact risk level is not clearly stated in the record.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0263-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0263-2024 from Sun Pharmaceutical. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
