药品召回是指药品生产企业按照规定的程序收回已上市销售的存在安全隐患的药品。在cGMP以下问答指南中，FDA对于药品召回的相关要求，以问题解答的方式给予了详细的说明。

问1：什么是召回？

答：召回是指公司采取的行动，将任何违反FDA管制法律的产品从市场上撤出。召回药品可以由公司自行发起，也可以应FDA的要求进行。违法的上市产品需要进行移除或纠正，对此可以FDA可发起法院诉讼，而召回是一种替代方式。根据FDA关于制剂CGMP法规（21 CFR 211.150(b)），生产商必须建立并遵循书面程序，以促进从市场上召回有缺陷的产品。

§211.150分销程序

Sec. 211.150 Distribution procedures.

建立并遵循书面程序，描述药品的分销。应包括：

Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

（b）一种系统：据此可以容易地确定每批药品的分销情况，以在必要时方便召回。

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

Q1. What is a recall?

A: Recalls are actions taken by a firm to remove from the market any product that is in violation of laws administered by FDA. Recalls of a drug may be conducted on a firm’s own initiative or by FDA request. A recall is an alternative to an FDA-initiated court action for removing or correcting violative, distributed products. Under FDA’s CGMP regulations for finished pharmaceuticals, manufacturers must establish and follow written procedures to facilitate the recall of defective products from the market (see 21 CFR 211.150(b)).

问2：FDA可以强制召回人药吗？ 

答：FDA无权强制召回人药，但可以对那些坚持销售有缺陷产品（例如扣押和禁令）的 生产商采取更权威的法律行动。召回是指公司对FDA认为违反其管制法律的产品进行移除或纠正，否则FDA将针对此产品采取更强有力的法律行动。因此，生产商通常会发现市场批次缺陷时主动发起自愿召回，以避免FDA可能采取更重大的执法行动。

Q2. Can FDA mandate a recall of human drugs? 

A: FDA does not have authority to mandate a recall of a human drug, but it can take more authoritative legal actions against manufacturers that persist in marketing a defective product, such as seizure and injunction. A recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers, and against which FDA would otherwise initiate more powerful legal action. Thus, manufacturers typically initiate voluntary recalls when a defect is found within a marketed batch to avoid a potentially more significant enforcement action by FDA. 

问3：非处方药是否与处方药一样，受召回规定的约束？ 

答：是的，FDA对药品的召回期望同样适用于非处方药和处方药。CGMP法规也适用于所有药品，无论是非处方药还是处方药。 

Q3. Are over-the-counter (OTC) drugs subject to the same recall provisions as prescription drugs? 

A: Yes, FDA’s recall expectations for drugs apply equally to OTC and prescription. The CGMP regulations also apply to all drug products, whether OTC or prescription. 

问4：FDA是否期望企业对已放行和拒绝的批次进行调查，以发现潜在的召回需求？

答：是的。根据21 CFR 211.180(e)，生产商必须建立并遵循书面程序，以定期回顾投诉、召回、退回或回收处理的药品以，并对产品差异性问题进行调查。公司还必须审查适当数量的批次（无论已批准还是已拒绝放行），以及与批次相关的记录（如适用），以确保对所有可能受影响的产品进行彻底调查，并采取适当的后续措施（21 CFR 211.192）。 

Q4. Does FDA expect firms to investigate both released and rejected lots for potential recalls?

A: Yes. Under 21 CFR 211.180(e), manufacturers must establish and follow written procedures for periodically reviewing complaints, recalls, returned or salvaged drug products, and investigations of product discrepancies. Firms must also review an appropriate number of batches, whether approved or rejected, and, where applicable, records associated with the batches, to ensure that all potentially affected product is thoroughly investigated and appropriate follow-up action is taken (21 CFR 211.192). 

问5：如果公司不自愿召回有缺陷的产品怎么办？

答：如果药品有缺陷，对健康造成危害，FDA希望公司会自愿召回。当公司拒绝执行FDA要求的召回时，或FDA有理由认为召回无效、确定召回无效或发现违反行为仍在继续时，FDA将采取扣押、查封或其他法院行动。

Q5. What happens if a firm does not voluntarily recall a defective product?

A: FDA expects that a firm will voluntarily recall a drug that is defective or flawed if it could be hazardous to health. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by FDA, or where the Agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing (21 CFR 7.40(c)).