FDAClass IIApril 5, 2017

Atorvastatin Calcium Tablets recall: Sterility Concern

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc.…

Why was Atorvastatin Calcium Tablets recalled?

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

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 #: 3084288, Exp. 07/18

Product
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc.…
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Quantity
1,527 cartons
Distribution
Nationwide in the USA
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls