In a drug recall, a pharmaceutical company or a regulatory authority initiates the withdrawal of a product or certain batches of a product from the market because problems have been discovered that could endanger the health or safety of patients. It is a measure that is taken when a drug does not meet quality standards, is defective or when new information about the risks associated with its use emerges.

Reasons for the recall (German translation: Rückruf) of drug or batches of a drug:

• Safety concerns: Determining that there are severe side effects that were not known at the time the drug was approved can be grounds for a drug recall.
• Quality defects: Manufacturing errors, contamination, incorrect labeling or packaging defects usually lead to the recall of individual batches (German: Chargen).
• Lack of efficacy: Signs of a loss of efficacy, e.g. after improper storage, may make a recall necessary.
• Non-compliance with legal regulations: Changes in legal regulations may mean that a drug’s formulation, packaging (German translation: Verpackung) or instructions for use must be changed.

Drug recalls can be divided into three classes according to the European Rapid Alert System (RAS), Class I being the highest degree of risk.

• Class I: Recall of drugs that pose a serious risk to a patient’s health or risk of death.
• Class II: Recall of drugs that may cause adverse health effects that are temporary or can be managed with proper medical intervention.
• Class III: Recall of drugs that have defects that violate quality standards but do not pose an immediate health risk.

Once a defect has been identified, a risk assessment is carried out and a decision is made as to whether a recall is necessary. Recalls are usually carried out at the levels of wholesalers and pharmacies, but in particularly serious cases, a recall can also be carried out at patient level. Information about the recall is published in specialized press and online. The drug in question or the respective batches can then no longer be sold and must be sent in or disposed of.

Drug recall is an important measure to protect public health. This procedure underlines the importance of systems for monitoring the safety and quality of drugs once they are on the market.

GMP-inspection.com employs experienced pharmaceutical interpreters and GMP translators who provide you with competent and reliable support for your GMP inspection and who can also translate your pharmaceutical documents.

We also offer the following services: Consultancy in the run-up to GMP inspections, representation of international pharmaceutical companies and distribution of their products in Germany. If you are looking for a new career opportunity in the pharmaceutical industry, we will be happy to support you by getting in touch with our contacts at a large number of pharmaceutical companies.