; and (B) there is a reasonable probability that the use or consumption of, or exposure to, the drug (or an ingredient or component used in any such drug) will cause a threat of serious adverse health consequences or death to humans or animals. (2) Manner of notification Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation or guidance. (b) Voluntary recall The Secretary may request that any person who distributes a drug that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily— (1) recall such drug; and (2) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall. (c) Order To cease distribution and recall drug and related procedures (1) Issuance of order If the Secretary has reason to believe that the use or consumption of, or exposure to, a drug (or an ingredient or component used in any such drug) may cause serious adverse health consequences or death to humans or animals, the Secretary shall have the authority to issue an order requiring any person who distributes such drug— (A) to immediately cease distribution of such drug