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Class III · Lower riskRecall completed

Atorvastatin Calcium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: RC5439 Exp. 03/2022
Where it was soldIL, MS, NJ, OH, TX
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: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 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 byApotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 foreign manufacturer
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Distributed by / forApotex Corp. Weston, Florida 33326
NDC60505-2580-8
Show the full FDA record
Full product labelAtorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8
Recalling firmApotex Inc.
DistributionIL, MS, NJ, OH, TX
Quantity1968 bottles
Recall initiated2019-10-22
Report date2019-11-06
Recall completed2026-02-19
Recall numberD-0153-2020
ClassificationClass III
FDA statusTerminated
Origin on fileNorth York Canada

Related

Atorvastatin recallsRecent drug recallsCheck another medication

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.