Shimoga Chemicals — Class II: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG
Shimoga Chemicals has initiated a Class II recall for several net weight configurations of Clomiphene Citrate USP Active Pharmaceutical Ingredient (API) due to documented cGMP deviations. The recall is currently classified as ongoing and involves products manufactured at their facility in Maharashtra, India.
This recall affects pharmaceutical manufacturers, compounding pharmacies, and distributors who utilize Shimoga Chemicals Clomiphene Citrate API (CAS: 50-41-9) in the production of finished dosage forms.
A Class II recall due to cGMP deviations at the API level suggests potential deficiencies in the manufacturing process, facility environment, or quality control systems. While the source does not specify the exact nature of the deviations, such failures typically call into question the identity, strength, quality, or purity of the raw materials, potentially necessitating downstream recalls of finished drug products.
Supply chain and procurement teams should immediately quarantine any Clomiphene Citrate API sourced from Shimoga Chemicals. Quality units should conduct a risk assessment for any finished drug products manufactured using these batches to determine the impact of the reported cGMP deviations on product quality.
Class II. Reason: cGMP deviations. Product: 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.. Firm: Shimoga Chemicals (Sangli N/A India). Status: Ongoing.
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