Why Is My Medication Recalled?
Medications available for use in the US are prepared under strict standards set by the US Food and Drug Administration (FDA) to safeguard quality, safety, and efficacy. Occasionally situations arise after marketing of the medicine to require a recall of the products. Recalls are issued to protect consumers from defective or potentially harmful products.
Who determines that a recall be issued?
A recall may be initiated by the manufacturer or by the manufacturer at the request of the FDA for prescription and OTC drugs.
Are all recalls of equal concern?
Based on severity of harm, the FDA classifies recalls into 3 groups – Class I, Class II, and Class III.
- Class I – A dangerous or defective product that could cause serious health problems or death.
- Class II – A product that might cause a temporary health problem or pose a slight threat of a serious nature.
- Class III – A product that is unlikely to cause any adverse health effects but violates FDA labeling or manufacturing standards.
What type of recalls are the most common?
A published study analyzed more than 15,000 recalls that were reported over a decade. They noted 1,500 recalls for class I, 1,500 for class III, and over 12,000 class II recalls. Detailed reasons for these recalls in the top categories include:
- Manufacturing issues including failure to follow standards for production, storage, and packaging
- Sterility issues, most commonly in injectable products and may include leakage or improper sealing of product
- Issues such as impurities or too much or too little drug in the final product
- Contamination due to chemicals, other drugs, germs, or other substances
- Labeling issues such as label mix-ups or incorrect information on the label
How do I know if my medication is recalled?
You may receive a notification from your pharmacy or hear about it in the news media. Additionally, you can check for recalls on the FDA website. You can also check with your pharmacist to verify that your medication is affected by the recall.
What should I do if my medication is recalled?
Talk to your pharmacist to see if a replacement is available for your medication that is unaffected by the recall or from another manufacturer. Do not abruptly stop taking your medication, unless that is specifically noted in the recall. If your medication is not available, then your doctor can recommend a similar medication for you to take.
Summary
If your medication is recalled continue taking it until you can verify the recall with your pharmacist and find a replacement for your medication treatment. Talk to your pharmacist if you have any questions about the reason for the recall.