FDAClass IIIOctober 22, 2014

Vasotec recall: Labeling Error

Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct…

Why was Vasotec recalled?

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

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?

VASOTEC 2.5MG TAB 30CT 12K015P exp. 9/30/2014 VASOTEC 2.5MG TAB 30CT 13G048P exp. 07/31/2015 VASOTEC 2.5MG TAB 30CT 14A065P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 13G020P exp. 07/31/2015 VASOTEC 2.5MG TAB 90CT 12K020P exp. 9/30/2014 VASOTEC 2.5MG TAB 90CT 13B016P exp. 9/30/2014 VASOTEC 5MG TAB 30CT 13B022P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13B023P exp. 2/28/2015 VASOTEC 5MG TAB 30CT 13C015P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 13E002P exp. 02/28/2015 VASOTEC 5MG TAB 30CT 14A002P exp. 11/30/2015 VASOTEC 5MG TAB 30CT 13L066P exp. 11/30/2015 VASOTEC 5MG TAB 90CT 13B018P exp. 2/28/2015 VASOTEC 5MG TAB 90CT 13G015P exp. 06/30/2015 VASOTEC 10MG TAB 90CT 12M017P exp. 11/30/2014 VASOTEC 10MG TAB 1000CT 12L105P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 12M016P exp. 11/30/2014 VASOTEC 10MG TAB 30CT 13G013P exp. 06/30/2015 VASOTEC 10MG TAB 30CT 13J081P exp. 9/30/2015 VASOTEC 10MG TAB 90CT 12M025P exp. 11/30/2014 VASOTEC 10MG TAB 90CT 13J082P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J085P exp. 0/2015 VASOTEC 10MG TAB 90CT 13J094P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13J098P exp. 09/30/2015 VASOTEC 10MG TAB 1000CT 13G011P exp. 06/30/2015 VASOTEC 10MG TAB 1000CT 13J097P exp. 09/30/2015 VASOTEC 20MG TAB 30CT 12J017P exp. 5/31/2014 VASOTEC 20MG TAB 30CT 13C016P exp. 2/28/2015 VASOTEC 20MG TAB 30CT 13E003P exp. 02/28/2015 VASOTEC 20MG TAB 30CT 13L068P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J086P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 13J087P exp. 09/30/2015 VASOTEC 20MG TAB 90CT 12M029P exp. 11/30/2014 VASOTEC 20MG TAB 90CT 12M030P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 12J023P exp. 5/31/2014 VASOTEC 20MG TAB 1000CT 12L108P exp. 11/30/2014 VASOTEC 20MG TAB 1000CT 13C088P exp. 02/28/2015 VASOTEC 20MG TAB 1000CT 13J099P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M054P exp. 09/30/2015 VASOTEC 20MG TAB 1000CT 13M055P exp. 12/31/2015 VASOTEC 20MG TAB 1000CT 14B054P exp. 12/31/2015

Product
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct…
Recalling firm
Valeant Pharmaceuticals North America LLC
Quantity
205,853 bottles
Distribution
Nationwide
Recall date
October 22, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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