FDA-Drug2025-04-09Class II
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
BIOCON PHARMA INC
Hazard
Failed dissolution specifications: lower than specifications
Sold states
U.S.A. nationwide
Affected count
2184 bottles
Manufactured in
485 HWY 1 (S), ISELIN, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0306-2025Don't want to check this manually?
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