FDA-Drug2020-02-12Class II
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.
Graviti Pharmaceuticals Private Limited
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.
Sold states
Nationwide in the USA.
Affected count
29,056 bottles
Manufactured in
Survey No. 621 Isnapur Village, Patancheru Mandal, Medak, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0832-2020Don't want to check this manually?
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