D-0306-2025 Class II Ongoing

Recalled by BIOCON PHARMA INC — ISELIN, NJ

Recall Details

Product Type
Drugs
Report Date
April 9, 2025
Initiation Date
March 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2184 bottles

Product Description

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

Distribution Pattern

U.S.A. nationwide

Code Information

Lot#: AVC24035, Exp 03/31/26