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Class II · ModerateRecall completed

Pravastatin Sodium

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

Does this affect you?
Check your lot numberBatches: R2201233, Exp. Date 4/30/2024
Where it was soldUnited States including Puerto Rico and Canada
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

CGMP Deviations: recalling drug products following an FDA inspection.

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 byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA foreign manufacturer
Brand namePRAVASTATIN SODIUM
Generic namePRAVASTATIN SODIUM
Active ingredient(s)PRAVASTATIN SODIUM
Distributed by / forAccord Healthcare, Inc., Durham, NC 27703
NDC16729-011-15
Show the full FDA record
Full product labelPravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0
Recalling firmAccord Healthcare, Inc.
DistributionUnited States including Puerto Rico and Canada
Quantity1970 bottles
Recall initiated2023-02-07
Report date2023-03-08
Recall completed2024-04-22
Recall numberD-0424-2023
ClassificationClass II
FDA statusTerminated
Origin on fileDurham NC United States

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.