New and Updated Drug Shortages List 8/27/14
By Cyndi Root
The Food and Drug Administration has published its new and updated Drug Shortages through 8/27/14. The federal agency publicizes recalls on its website as press releases are not issued for all shortages. View the recalls by New and Updated.
New Drug Shortages
Fresenius Kabi USA, Mylan Institutional and X-Gen Pharmaceuticals report a shortage of Clonidine HCL Injection (duraclon). Mylan and Fresenius Kabi state that the shortage is due to increased demand and X-Gen states that its shortage is because of a shortage of an active ingredient, expected to be available at the end of September. Clonidine HCL Injection is used with epidural infusion devices as an analgesic.
Fresenius Kabi USA, Mylan Institutional, and West-Ward Pharmaceuticals are short of Famotidine Injection, a stomach acid neutralizer, due to increased demand and manufacturing delays. West-Ward has accelerated production and Fresenius Kabi expects to release the product at the end of September.
Paragon BioTeck is currently reporting a shortage of Phenylephrine Hydrochloride Ophthalmic Solution, an ophthalmologic vasoconstrictor and mydriatic. The company reports few details except that the product has limited availability and will recover in September.
Mikah Pharma and Teva are experiencing shortages of Trimipramine Maleate (surmontil) capsules. Mikah states that the shortage is due to a shortage of an active ingredient, as an API manufacturer discontinued the ingredient. Teva states no reason but that the replenishment is expected by mid-September. Trimipramine Maleate is an antidepressant with a sedative component.
Updated Drug Shortages
In this review, 43 drug shortages were updated. All but two are for injections or for injection bags. Actavis, Sandoz, and UCB, among others, are all short of Methylphenidate Hydrochloride tablets. Mallinckrodt states that these tablets, indicated for Attention Deficit Disorder (ADHD), are now available, while Sandoz states that the drug is currently on backorder as the API needs to be re-qualified. The drug, boasting the trade names Concerta, Methylin, Ritalin, and Equasym XL, has been short since February 2013.
Dextrose 5% Injection Bags have been short since May of 2014 due to increased demand. Baxter expects to have the product available in Q4 of 2014. Hospira has some formulations available and some due in August. The agent is a source of water and calories for adults and pediatric patients.