Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
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.
Compare with the code on your package — it is the most precise check available.
Drug: Atorvastatin Category: Cholesterol Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed dissolution specifications: lower than specifications
Presence of Foreign Substance
Failed Tablet/Capsule Specifications
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