Shimoga Chemicals recalls Clomiphene Citrate USP Active Pharmaceutical Ingredient

Clomiphene Citrate USP active pharmaceutical ingredient (CAS 50-41-9) in 1 kg (NDC 84849-000-01), 500 g (NDC 84849-000-02) and 100 g (NDC 84849-000-03) packages labeled Rx Only from Shimoga Chemicals (W‑57A, MIDC Kupwad Sangli, Maharashtra, India) with lot numbers CC/004/24‑25 (exp Sep 2029), CC0032526 (exp Aug 2030), CC0442526 (exp Aug 2030), CC/005/24‑25 (exp Nov 2029), CC/009/24‑25 (exp Jan 2030) sold in California and Florida is being recalled. The product was recalled due to cGMP deviations.

What's being recalled

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.

Recalling firm: Shimoga Chemicals, Sangli, N/A, India.

How to identify it

Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.

The hazard

cGMP deviations

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

CA & FL only

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)