Drug Enforcement D-0306-2025

Failed dissolution specifications: lower than specifications

Status

Ongoing

Classification

Class II

Report Date

April 9, 2025

Termination Date

—

Product Information

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
Product quantity
2184 bottles
Reason for recall
Failed dissolution specifications: lower than specifications
Recall initiation reason
—
Initial firm notification
—
Distribution pattern
U.S.A. nationwide

Location & Firm

Recalling firm
BIOCON PHARMA INC
Address
485 HWY 1 (S)

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0306-2025
Event ID
96496
Recall initiation date
March 17, 2025
Center classification date
March 28, 2025
Code info
Lot#: AVC24035, Exp 03/31/26
More code info
—