FDA recall D-0832-2020

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.

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

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2020-01-28

Report date

2020-02-12

Termination date

2022-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medak, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0832-2020