D-0832-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2020
- Initiation Date
- January 28, 2020
- Termination Date
- November 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,056 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: ATA318099C, Exp 12/2020