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Sec. 400.900 Class I Recalls of Prescription Drugs (CPG 7132.01)
BACKGROUND:
A Class I recall is an emergency situation involving removal from the market of a
product in which the consequences are immediate or long-range, life threatening, and
involve a direct cause-effect relationship. Class I recalls can, if necessary, require
retrieval of the recalled article from consumers (users). The pattern of distribution of
prescription drugs to consumers is different from that of other articles. Retrieval of
drugs when in the possession of consumers must take into consideration the doctor/patient
relationship.
POLICY:
When there is a Class I recall of a prescription drug, retail level consignees (retail,
hospital, nursing home pharmacists) will be required to review their prescription files
for the appropriate time period consistent with the period of distribution of the drug, in
order to identify all customers to whom the recalled drug was dispensed. The pharmacist
must notify those customers' physicians of the specific problem, and keep a record of the
physician notifications. The physician will be responsible for deciding whether his
patients are to be contacted.
If the pharmacist cannot distinguish in his prescription records between those
customers to whom the lot(s) of recalled drug was dispensed, and those who received the
same drug from a lot not under recall, or from a different manufacturer, then the
pharmacist, as a precautionary measure, must notify the physicians of all customers who
received the drug.
If retail level consignees (pharmacists, hospitals, dispensing physicians) cannot
identify persons to whom a drug under Class I recall was dispensed, there must be a
warning issued by FDA to the general public.
Issued: 10/1/80