FDAFDA · Food and drugs·Recall number D-0001-2025
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.
Published October 9, 2024 · Recall initiated: September 24, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Nivagen Pharmaceuticals Inc
- Distributor
- Nationwide within the U.S
- UPC
- 0375834258027
- Lot
- Lot #: U24T0408A, Exp: 03/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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