Reported Feb 12, 2020 · Terminated

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for

Graviti Pharmaceuticals Private Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Graviti Pharmaceuticals Private Limited · Survey No. 621 Isnapur Village · Medak, N/A · N/A

Is this the product you have?

Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for

3 of 3 products

Products covered by this recall
#Product as published
1Biocon Pharma Inc., Iselin, NJ 08830-3009 USA
2Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA
3NDC 70377-027-11.
Lot codes and dates
    • Lot #: ATA318099C
    • Exp 12/2020
Amount recalled
29,056 bottles

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 29, 2022 · Data as of Sep 19, 6:33 PM UTC

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