Keeping you informed
The Food and Drug Administration (FDA) ensures that a drug is safe and effective before it is available on the market. The FDA can recall a drug so it is not available.
A recall can happen when a drug is found to be either defective or could be harmful for use.
There are 3 types of recalls required by the FDA. The type of recall is based on the level of danger involved:
- Class I: Dangerous or defective products that could cause serious health problems or death. Example: A label mixed up on a lifesaving drug.
- Class II: Products that might cause a short-term health problem or pose only a slight threat of a serious nature. Example: A drug that is under-strength but is not used to treat life-threatening illness.
- Class III: Products that may not cause any bad health reactions, but violate FDA labeling or manufacturing laws. Example: A minor pill bottle defect.
Drug companies may also decide to remove a drug or product for other reasons. This is called withdrawal. Example: A drug is removed from the market due to tampering.
The AlohaCare Pharmacy Department will tell members, doctors, and pharmacies when there is a Class I or Class II drug recall. We also inform our members in writing when drugs are withdrawn from the market for safety reasons.
AlohaCare reviews drug recalls and withdrawals every 3 months. The review takes place in a meeting with a group of pharmacists, doctors, and nurse practitioners. This meeting is called the Pharmacy and Therapeutics (P&T) Committee.
Please talk to your doctor about any details on drug recalls and withdrawals that may affect you.