Drug Recalls: What You Need to Know

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Believe it or not medication recalls happen on a daily basis, for all kinds of reasons. The severity of recalls can range from very minor to potentially life-threatening incidents if they aren’t immediately taken care of.

Are there different types of drug recalls?

Yes. Drug recalls are broken down into the following classes:

What is a Class I recall?

A Class I recall is the most serious type of recall. The FDA defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Example: The current gabapentin recall.

What is a Class II recall?

A Class II recall is the most common type of recall, and not as serious as a Class I. According to the FDA, a Class II recall is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Example: In 2010 the recall of various lots of injectable ketorolac due to the possibility of tiny particles in the vial.

What is a Class III recall?

Class III recalls are the least serious, and Class III recalled products aren’t likely to cause adverse consequences.

Example: In 2008 the recall for fentanyl patches due to leaking of fentanyl gel potentially exposing patients or their caregivers to the drug without applying the patch.

Who can recall a drug?

A manufacturer can voluntarily initiate a recall, or the Food and Drug Administration (FDA) can either request or require that a manufacturer recall a particular medication.

The majority of recalls are voluntary. The FDA rarely requests a recall but they do play a supervisory role to make sure the company does everything properly to ensure the safety of those affected by the recall.

What type of medication recalls is the FDA involved in?

The FDA has control over recalls ranging from human drugs, vaccines, medical devices, and biological products; to cosmetics and food; to food and drugs intended for animals.

What is the significance of recalls?

The use of a recalled medication, depending on the recalled reason, may result in physical harm.

To use the recent gabapentin recall as an example, a medication that has empty capsules in the batch can lead to missed doses—which could result in decreased effectiveness, short-term withdrawal, and seizures if you are using this medication to prevent them.

However, not all recalls are this serious. Another example of a recent but less dangerous recall is the over-the-counter lubricant eye drop Oasis TEARS. This product was recalled because in one particular lot, the actual bottle wasn’t labeled in the packaging. Even if the medication inside the bottle is correct, it can be scary if you receive an unlabeled product.

How are patients notified if their medication is recalled?

You may be notified by telephone, mail, fax, or email if your medication or medical device has been recalled.

Recall information may also be posted on the manufacturer website, however, this isn’t the primary means of providing notification to patients.

Who notifies a patient if their medication is recalled?

You may be notified by the FDA, the manufacturer, or the dispensing pharmacy.

Sometimes the FDA will publically announce a recall via news and other media to reach more people; however, not all recalls are announced in the media.

In July 2011, the FDA began a program to notify people of drug recalls before they are grouped into classes I, II, or III as mentioned above. The unclassified recalls are published every Wednesday in the Enforcement Report titled Human Drug Product Recalls Pending Classification, which can be found here.

You can also sign up here to receive e-mail alerts regarding recalls, or you can follow @FDArecalls on Twitter for more information.

What should I do if I have questions about a recalled product?

You can contact the manufacturer of the product via telephone, email, or through their website. Contact information is also typically included in the recall announcements.

You may also contact the FDA with any questions or concerns:

• Toll free phone numbers: (855) 543-3784 or (301) 796-3400
• Email: druginfo@fda.hhs.gov
Drug Recalls webpage
Where can I find more information on animal & veterinary recalls?

Check out the FDA webpage for Recalls & Withdrawals for animal & veterinary products here.

Where can I find out more information on biologic recalls?

Check out the FDA webpage for Recalls on Biologic products here.

How can I find out more information on medical device recalls?

Check out the FDA webpage for Recalls on Medical Devices here.

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