Recall: Enalapril/HCTZ and Losartan

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Apotex has issued a voluntary recall of several lots of generic blood pressure medications enalapril/hydrochlorothiazide (enalapril/HCTZ, generic Vaseretic) and losartan (generic Cozaar).

This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse effects is remote. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled one lot of enalapril/HCTZ 10 mg/25 mg tablets, and four lots of losartan 25 mg, 50 mg, and 100 mg tablets.

Why are the losartan and enalapril/HCTZ tablets being recalled?

The recall is based on the discovery that the affected lots of both medications did not meet FDA regulatory requirements for blend uniformity specification. This means that the tablets can differ greatly from each other from one lot to the next, which is not acceptable by either FDA or manufacturing standards.

When was the recall initiated?

The affected lots of both enalapril/HCTZ and losartan were recalled by the manufacturer on June 24, 2015.

How long have the affected products been in pharmacies?

The recalled lot of enalapril/HCTZ 10 mg/25 mg tablets started shipping over a year ago, on February 13, 2014.

The recalled lots of losartan 25 mg, 50 mg, and 100 mg tablets started shipping almost two years ago, on September 20, 2013.

Are patients being notified who have taken either of these medications?

No. These are both class II recalls, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.

If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.

Which enalapril/HCTZ products were affected?

In this recall, only one lot and one strength were affected.

Drug: enalapril/HCTZ 10 mg/25 mg tablets, 100-count bottle
Manufacturer: Apotex
Lot: KP4529, expiration 10/2015
National Drug Code (NDC): 60505-0209-01

Which losartan products were affected?

In this recall, four total lots of three different strengths were affected.

Drug: losartan 25mg tablets, 90-count bottle
Manufacturer: Apotex
Lot: KP4726, expiration 09/2015
National Drug Code (NDC): 60505-3160-09

Drug: losartan 50mg tablets
Manufacturer: Apotex
Lot: KN1499, expiration 06/2015
National Drug Code (NDC): 60505-3161-09

Drug: losartan 100mg tablets
Manufacturer: Apotex
Lots: KT3819 and KT3821, expiration 11/2015
National Drug Code (NDC): 60505-3162-09

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