The gathering of nimesulide drugs 50mg / ml and 50mg erythromycin estolate / ml pharmaceutical suspension medium, it was a precautionary action Anvisa, manufactured because of the stability and dissolution studies with altered production process. The stability studies results are used to establish or confirm the expiration date and to recommend storage conditions.
In this context, it is possible not to ratify the validity and performance of these drugs compared with the recorded condition. For diclofenac sodium 50mg, tablet, Anvisa’s decision was also precautionary, based on the validation of the production process, which ensures the reproducibility of the lots within the parameters established in the drug registration. The change in the production process may involve inclusion or modification of equipment or some modification during production of the drug.