Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 088
Summary
The FDA issued a Class II for Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured by BIOCON PHARMA INC. Reason: Failed dissolution specifications: lower than specifications.
Details
Source
Drug Recall
External ID
D-0306-2025
Action Date
2025-04-09
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: AVC24035, Exp 03/31/26
Quantity Affected: 2184 bottles
Reason for Recall
Failed dissolution specifications: lower than specifications
Distribution
U.S.A. nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-17
Company
ISELIN, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
BIOCON PHARMA INC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BIOCON PHARMA INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BIOCON PHARMA INC have FDA actions?
BIOCON PHARMA INC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0306-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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