Manufacturing mess-ups can lead to recalls, recalls to shortages and shortages to hardships on patients. Mylan ($MYL) and Health Canada have rethought a recall of Mylan-Nitro Spray that it hopes will not deprive users of the meds they need for angina. The effort comes as the FDA has been fighting a shortage of nitroglycerin in the U.S.
Health Canada issued the recall on Saturday of all lots of Mylan-Nitro Spray 0.4 mg/metered dose because some of them might be missing the "dip tube," which is part of the pump component. "This defect may lead patients to believe they are receiving the nitroglycerin, when in fact they are unable to access it. Not receiving nitroglycerin could place them at risk for either a delay in treatment for their angina or of suffering a heart attack."
Twenty-four hours later, the agency revised the recall. It said it determined that a shortage would occur from an immediate recall, so Mylan Pharmaceutical was suggesting that pharmacists provide affected consumers with two new spray canisters of Mylan-Nitro Spray. The agency said it decided on the action after it considered all factors.
The company told the agency that the chance of patients getting a bad canister was low and those missing dip tubes can still deliver between 70 and 75 doses rather than the usual 200 sprays. It said it would recall the rest of the canisters once it got supply of the product stabilized. Until then, the company suggested that patients carry a spare canister with them and get refills more often. It also warned patients not to try to open a can to see if it was missing its dip tube.
A shortage of nitroglycerin in the U.S. this year has been tied to manufacturing problems. The FDA earlier this year started allowing Arbor Pharmaceuticals to temporary import some non-FDA-approved nitroglycerin in 5% dextrose injection products from a plant in Germany to help hospitals maintain supplies during the shortage. Baxter International ($BAX) and Hospira ($HSP) both recently indicated they had product available again after issues had run their supplies short of demand. The FDA has been doing the same thing with saline solution in the face of a shortage of it that has been going on for months.