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drug recalls
recalls, pharm tech
| Question | Answer |
|---|---|
| drug or product recall | can be initiated by the manufacturer (voluntary) or the FDA |
| Class I | highest level of recall; products that can cause serious harm or prove fatal. This includes life saving drugs, foods that contain toxins, or labels that do not list ingredients that may cause allergies |
| Class II | products that may cause a temporary health problem or pose a slight threat of serious harm. This level includes drugs that are dispensed at less than the strength labeled on the container. It does not include drugs used in life threatening events |
| Class III | the lowest level of recall; used for products that may have a minor defect or other condition that would not harm the patient but prevents the drug from being resold. This level includes a drug container defect (i.e. a faulty cap), a product with a strange color or taste, or the lack of English labeling on retail food items |
| information contained in a recall notice | drug manufacturer's name, drug name, strength, package size, lot (batch) number, and expiration date |
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DbaileyC
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