D-0832-2020 Class II Terminated

Recalled by Graviti Pharmaceuticals Private Limited — Medak, N/A

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