Let’s start at the beginning…
A drug recall is issued when a drug becomes dangerous to the consumer. The Food and Drug Administration (FDA) monitors drug safety prior to going on the market and continues after a drug is introduced to the market.
Should any unforeseen issue arise in regards to the drug’s effectiveness and safety, the FDA or the drug manufacturer will issue a drug recall and take it off the market. Recalls happen for a number of reasons including safety, mislabeling or poor packaging, contamination, or if the medication is in violation of FDA laws and regulations.
Drug Recalls in the U.S. are classified into three different categories depending on the severity of harmful effects.
Class I: products that could cause serious health problems or death;
Class 2: products that may cause a temporary or reversible adverse health problem or where the probability of a serious health problem is remote; and
Class 3: products that are unlikely to cause any adverse health problems but violate FDA manufacturing or labeling laws.
Whether voluntary or issued by the FDA, a recall notice will:
- Contain specific information regarding the affected product such as NDC number, lot number and expiration dates that are subject to recall.
- Provide a form that is required to be submitted with the product when it is returned. This form is either sent to the pharmacy with the recall notice or obtainable from a link given on the recall notice.
- Provide specific instructions regarding where to send the recalled product for return.
- Indicate a specific period of time during which the recalled product can be returned for reimbursement credit.
Returns Processing of Recalls
GRx accepts recalled product as part of returns services offered to the market. GRx maintains a database of current recalled products by NDC and Lot numbers. Incoming recalled product is immediately identified using our recall database and the appropriate return actions are taken in accordance with the recall instructions issued by the FDA or the manufacturer.
Whenever possible, separate recalls from your regular expired products (a plastic bag will do) and include the FDA recall notice.
It is important to note that recalled products are very rarely destroyed by GRx for a manufacturer as a recall almost always requires that the manufacturer take possession of the defective product to make sure that it is all accounted for, i.e., almost all recalled product is returned to the manufacturer.
At GRx, customers have access to the Recall Manifest through our online customer portal. This manifest will show recalls that were processed in each cycle.
We’d be happy to answer any questions you may have about how recalled products are processed at GRx or any questions regarding expired return services.