Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, In
Summary
The FDA issued a Class II for Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manuf by Nivagen Pharmaceuticals Inc. Reason: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets,.
Details
Source
Drug Recall
External ID
D-0001-2025
Action Date
2024-10-09
Status
Ongoing
Category
drug
Product Description
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Lot/Code Info: Lot #: U24T0408A, Exp: 03/31/2026
Quantity Affected: 2328 bottles
Reason for Recall
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Distribution
Nationwide within the U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-24
Company
Sacramento, CA
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 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Nivagen Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nivagen Pharmaceuticals Inc have FDA actions?
This is the only FDA action we have on record for Nivagen Pharmaceuticals Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0001-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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