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7 Cards in this Set
- Front
- Back
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FDA recalls are issued in one of three classes
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CLASS I RECALLS - those in which the product can cause serious health problems or death
CLASS II RECALLS - those products which can cause temporary health problems or a slight risk of a serious nature CLASS III RECALLS - those products which are unlikely to cause a health problem but still violate FDA regulations |
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example of each class
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A CLASS I recall would exist in a case such as a bottle labeled Dilantin capsules which contained Dyazide instead. A risk of serious health problems would exist if someone who needed Dilantin were to take Dyazide through an error in labeling.
A CLASS II recall would exist in a case such as Detrol 2mg tablets which contain tablets whose strength is 1.25mg. While there is a problem with strength here, the drug is not used to treat life threatening conditions and the understrength is not likely to cause serious health risks. A CLASS III recall would exist in a case such as Lanoxin 0.25mg bottle of #100 tabs which contains only #90 Lanoxin 0.25mg tablets. While there is a violation in labeling here, the product would not cause a risk to patient health. |
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Any drugs returned from a customer to a retail pharmacy should be:
marked with an "X" on the label and placed back into pharmacy stock reported to the DEA discarded in the appropriate means none of the above |
discarded in the appropriate means
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Schedule 2 drugs which are to be returned for destruction should always be:
preceded by a completed DEA form 222, copies 1 & 2 followed by a completed DEA form 222, copies 1 & 2 reported to the state police none of the above |
preceded by a completed DEA form 222, copies 1 & 2
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An advantage to using a collection company to return expired controlled drugs vs the DEA is:
the collection service is less expensive to use the DEA seldom grants return authorization the collection companies will work with manufacturers to try to obtain credit for surrendered drugs all of the above |
the collection companies will work with manufacturers to try to obtain credit for surrendered drugs
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When accepting returns of unit dose medications from inpatient nursing units, the drug:
must be discarded by the appropriate means may be placed back into the pharmacy's inventory and reused should be repackaged in new unit dose wrappings should be sent to the DEA |
may be placed back into the pharmacy's inventory and reused
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When a bulk drug is returned from an inpatient nursing area, the drug:
must be discarded by the appropriate means may be placed back into the pharmacy's inventory and reused should be repackaged and dispensed again should be sent to the DEA |
must be discarded by the appropriate means
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