Graviti Pharmaceuticals Private Limited recalls Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 0…
- Recall date
- January 28, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0832-2020
- FDA classification
- Class II
- Brand / firm
- Graviti Pharmaceuticals Private Limited
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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