Drug Safety Alerts

At CVS Caremark, our goal is to support you with the best possible pharmacy care by taking a proactive stance on drug safety alerts.

• Our dedicated Drug Safety Alert team monitors the U.S. Food & Drug Administration (FDA) website.

• We also check other manufacturer and pharmacy communications.

• We help ensure that all products we dispense are safe and effective.

CVS Caremark will notify you of the following three drug safety alerts:

• Recalls

• Market withdrawals

• Black box warnings

Recalls

Why are recalls issued?

The U.S. Food and Drug Administration (FDA) regulates manufacturing facilities of drug companies (manufacturers), both inside and outside the country. They may take actions if they find drug products with impurities beyond accepted levels. This means the FDA may recommend that a manufacturer conduct a recall, publish alerts or both. They’ll need to update providers, pharmacies, patients and others in the U.S. market that may have drug quality or safety issues. You can learn more about safety alerts at FDA.gov.

The FDA defines a recall as actions taken by a drug company to remove a product from the market. A drug company may volunteer to recall on their own, or the FDA may request the recall. The FDA defines its role in a recall as being “to oversee a company’s strategy, assess the adequacy of the recall, and classify the recall.”

Recall classifications

Recalls can be grouped as Class 1, 2 or 3. They’re ranked by health hazard, affected by the recalled product.

• Class 1 recall: There is a reasonable probability that the use of or exposure to the product will cause serious, adverse health consequences or death.

• Class 2 recall: The product “may cause temporary or medically reversible, adverse health consequences or where the probability of serious, adverse health consequences is remote.”

• Class 3 recall: Use of or exposure to the product “is not likely to cause adverse health consequences.”

Three types of recalls

As part of the recall strategy, the manufacturer works with the FDA to determine the “depth” of the recall. That means they decide who in the distribution chain are affected by the recall.

• Wholesale: The manufacturer removes the product from a warehouse or distribution center where the product is not under their direct control.

• Retail: The product is removed from retail stores.

• Consumer: The product has been sold to consumers. So, the public may need to be informed in addition to the product being removed from a warehouse and retail sale.

Recalls that impact CVS Caremark

Based on the FDA guidelines, if a consumer-depth recall happens, actions should be taken right away to remove the affected products from distribution and notify any consumers who may be at risk. In the case of a retail-depth recall, actions are taken right away to remove the affected products from distribution.

• Consumer-depth recall: This applies to patients or consumers and pharmacies.

• Retail-depth recall: This applies to pharmacies and health care providers that stock the recalled product. It does not include patients or consumers.

Market withdrawals

The FDA defines a market withdrawal as “a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation.”

A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal. Market withdrawals for safety reasons are processed in the same manner as recalls.

Black box warning

A black box warning appears in a box on a prescription drug's label. It’s designed to call attention to serious or life-threatening risks. The FDA requires a drug company to place a black box warning on a prescription drug label.

If you have questions about a recent boxed warning, call your doctor, a Customer Care representative at the number listed on your prescription card, or the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332), or visit FDA.gov.

Our priority is your health and safety

The health and safety of patients is our highest priority. We have policies and procedures in place to help ensure the medications we dispense are safe, reliable and of high quality. We also work to promptly respond to any product recalls for affected drugs in our supply chain, including, where applicable, products that have been dispensed to patients. And, we work to minimize disruption of therapy and support continuity of care for patients.