Recall: Nexium 20 mg Capsules

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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AstraZeneca has issued a voluntary recall of one lot of Nexium 20 mg capsules. Nexium is used to treat several conditions, the most common being gastroesophageal reflux disease (GERD) or heartburn.

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 Nexium 20 mg capsules.

Why are the Nexium 20 mg tablets being recalled?

The recall of one lot of Nexium 20 mg capsules is based on the discovery that some bottles contained a different medication, Seroquel XR 150mg tablets. The concern is the potential for accidental exposure to Seroquel XR, an atypical antipsychotic medication, which could lead to unwanted side effects.

For more information on Seroquel XR please see the manufacturer website here.

When was the recall initiated?

The affected lot of Nexium 20 mg capsules was recalled by the manufacturer on June 12, 2015.

How long has the affected Nexium been in pharmacies?

The recalled lot of Nexium started shipping three months ago, on March 16, 2015.

Are patients being notified who have taken this medication?

No. This is a class II recall, 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 products were affected?

In this recall only one manufacturer and one individual lot were affected.

Drug: Nexium 20 mg capsules, 30-count bottle
Manufacturer: AstraZeneca
Lot: FC0064, expiration 05/2017
National Drug Code (NDC): 00186-5020-31

You can also see the packaging of the affected product here.

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