Recall D-0306-2025

US Class II Ongoing · initiated 2025-03-17

Recalling firm

BIOCON PHARMA INC, NJ

Product

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13

Reason for recall

Failed dissolution specifications: lower than specifications

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