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Class II · ModerateRecall completed

Atorvastatin Calcium Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: ATA318099C, Exp 12/2020
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGraviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; foreign manufacturer
Distributed by / forBiocon Pharma Inc., Iselin, NJ 08830-3009 USA;
NDC70377-027-11
Show the full FDA record
Full product labelAtorvastatin 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.
Recalling firmGraviti Pharmaceuticals Private Limited
DistributionNationwide in the USA.
Quantity29,056 bottles
Recall initiated2020-01-28
Report date2020-02-12
Recall completed2022-11-29
Recall numberD-0832-2020
ClassificationClass II
FDA statusTerminated
Origin on fileMedak N/A India

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.