Expiration dating of repackaged medications
Inasmuch as this chapter is for purposes of general information only, no statement in the chapter is intended to modify or supplant any of the specific requirements pertinent to Pharmacopeial articles, which are given elsewhere in this Pharmacopeia.).The stability and clinical effect of manufactured dosage forms can be greatly compromised by seemingly negligible alterations or inappropriate prescription compounding.
Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products Diocto Liquid and Diocto Syrup, both oral liquid docusate products manufactured by Pharma Tech.
cepacia, bacteria linked to recent patient infections.
Therefore, FDA recommends health care professionals and patients not use Pharma Techs liquid drug products.
In dosage forms, the following reactions usually cause loss of active drug content, and they usually do not provide obvious visual or olfactory evidence of their occurrence.
Esters and -lactams are the chemical bonds that are most likely to hydrolyze in the presence of water.