January 2020 FDA Recall Drug by Graviti Pharmaceuticals Private Limited
D-0832-2020 - Presence of Foreign Tablets/Capsules

This Class II drug recall was voluntarily initiated by Graviti Pharmaceuticals Private Limited on January 28, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0832-2020

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.
Initiated
01-28-2020
Reported
02-12-2020
Quantity
29,056 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84814
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Graviti Pharmaceuticals Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-29-2022
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : ATA318099C, Exp 12/2020