FDAClass IIApril 17, 2019

Pravastatin Sodium Tablets USP recall

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ…

Why was Pravastatin Sodium Tablets USP recalled?

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 17181491 Exp. Aug. 2021

Product
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
2076 500-count Bottles
Distribution
Nationwide in the USA
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls