Shimoga Chemicals recalls Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations. This is a drug product for medical use only.
cGMP deviations
Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient (NDCs 84849-000-01 to 000-03) because of cGMP deviations. This product is used for medical purposes only and should be handled with care as it involves pharmaceutical quality issues.
cGMP deviations refer to failures in the manufacturing process that could affect the quality, safety, and effectiveness of the drug. This means the product might not meet the required standards for medical use, potentially leading to health risks if used improperly.
People who have the Clomiphene Citrate USP Active Pharmaceutical Ingredient (NDCs 84849-000-01 to 000-03) from Shimoga Chemicals in India are affected. Healthcare providers and patients using this medication are most at risk due to the cGMP deviations.
Check for the product names Clomiphene Citrate USP Active Pharmaceutical Ingredient with net weights of 1 kg, 500 g, or 100 g. Look for NDC numbers 84849-000-01, 84849-000-02, or 84849-000-03. The product is sold in India by Shimoga Chemicals.
Identify the NDC numbers (84849-000-01, 84849-000-02, or 84849-000-03) and net weights (1 kg, 500 g, or 100 g) on the product label.
The recall is due to cGMP deviations, which means the product may not meet quality standards. It is not safe to use without checking the recall status.
The official recall notice does not specify a remedy, so you should contact Shimoga Chemicals directly for guidance.
Visit the Shimoga Chemicals website or contact their address in Maharashtra, India for more details.
We’ve drafted a message you can send Shimoga Chemicals to request your refund or repair — edit it as you like.
Subject: Recall D-0691-2026 — Shimoga Chemicals Shimoga Chemicals Hello, I own a Shimoga Chemicals that is covered by recall D-0691-2026 from Shimoga Chemicals. 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.
