Sandoz Canada Initiates Precautionary Recall For One Morphine Lot And Works With Health Canada To Quickly Resupply Product
Sandoz Canada initiates precautionary recall for one morphine lot and works with Health Canada to quickly resupply product
Sandoz Canada announces it is initiating a voluntary, precautionary recall of a single lot of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoules (Lot CC2824, exp. 2014-12) due to a potential presence of ampoules of Isoproterenol HCl Injection USP 0.2 mg/mL in the morphine boxes. All ampoules found within the box are correctly labeled.
The recall is limited to a single lot of the drug, whose first sales were on March 2, 2012. The majority of the affected lot has not yet been released to the market and has been quarantined by Sandoz. To date, no adverse events have been reported in relation to the issue and Sandoz has received notification of only one occurrence of mixed product.
Sandoz has launched an internal investigation in order to determine the root cause of the incident. Sandoz is working closely with Health Canada to minimize the impact on product availability in light of the current market situation, and both have agreed to a visual re-inspection of all quarantined product prior to the quarantined product being released. All visually inspected product will be clearly marked with a sticker and supplied to the market as quickly as possible. Patients should consult their healthcare professional in the event of any concern.
"Although we are currently facing a challenging supply situation, we must take all measures to ensure patient safety at all times," said Sandoz Canada President Michel Robidoux. "Patients are our top priority and we remain committed to ensuring the quality and safety of all products."
About Sandoz Canada Inc.
Established in Boucherville, Quebec, Sandoz Canada is part of Sandoz International GmbH, the world's second largest producer of generic drugs and a subsidiary of the Swiss multinational corporation, Novartis. A leader in its field, Sandoz Canada develops, produces, markets and distributes a wide range of generic products used, among others, in anaesthesia, infectious diseases, oncology, cardiology, and pain management. The Boucherville manufacturing plant specializes in the production of key injectable products.
SOURCE: Sandoz Canada Inc.