Akorn's promethazine with codeine products have been subject to regulatory scrutiny and recalls. In 2022, Akorn voluntarily recalled multiple lots of their promethazine hydrochloride and codeine phosphate oral solution due to incorrect labeling. The product was mislabeled with the wrong strength, which could lead to a potential overdose if a patient receives a higher concentration than intended [1].
What happened with Akorn's promethazine with codeine recall?
The recall specifically affected promethazine hydrochloride and codeine phosphate oral solution, 6.25 mg/5 mL and 10 mg/5 mL. The mislabeling meant that the bottles contained the wrong strength of the active ingredients. Akorn initiated this voluntary recall after being notified by their supplier of the labeling issue [1].
Where can I find information on drug recalls?
Information on drug recalls, including those involving Akorn, can be found through regulatory bodies like the U.S. Food and Drug Administration (FDA). The FDA's website provides updates and details on recalls affecting pharmaceutical products [1].
What are the risks of mislabeled medication?
Mislabeled medication poses significant health risks. In the case of Akorn's promethazine with codeine recall, the incorrect strength could result in patients receiving a higher concentration of the drug than prescribed. This can lead to an overdose, potentially causing serious adverse events, including central nervous system and respiratory depression [1].
What is promethazine with codeine used for?
Promethazine with codeine is a prescription medication that combines an antihistamine (promethazine) and an opioid cough suppressant (codeine). It is typically prescribed to relieve symptoms such as cough and cold symptoms, as well as to alleviate moderate to severe pain [2].
What are the side effects of promethazine with codeine?
Common side effects of promethazine with codeine can include drowsiness, dizziness, constipation, nausea, and vomiting. More serious side effects, particularly with codeine, can involve respiratory depression, dependence, and abuse potential. Due to these risks, the use of this medication is carefully monitored [2].