FDAClass IIIMarch 16, 2016

Atorvastatin Calcium 10 mg recall: Impurity Out of Spec

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS…

Why was Atorvastatin Calcium 10 mg recalled?

Failed Impurities/Degradation Specifications

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 #GS005602; Exp. 10/15 Lot #GS008855; Exp. 09/17 Lot #GS009074; Exp. 08/17 Lot #GS009393; Exp. 08/17 Lot #GS009760; Exp. 10/17 Lot #GS010599; Exp. 11/17

Product
Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS…
Recalling firm
Golden State Medical Supply Inc.
Quantity
222 100-count packages (22,000 tablets)
Distribution
Nationwide
Recall date
March 16, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls