FDAFDA · Food and drugs·Recall number D-0832-2020
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
Published February 12, 2020 · Recall initiated: January 28, 2020
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: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: ATA318099C, Exp 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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