Sandoz and the FDA earlier this year struck a deal to let the generic unit of Novartis to import from a Canadian plant an infant parenteral nutrition product after a shortage arose in the U.S. Meanwhile, Sandoz is clearing the market of more than 50,000 vials of product that a contractor had produced for it after questions were raised about sterility at the facility where it was produced.
According to a recent FDA Enforcement Report, Sandoz on Nov. 9 began recalling 19 lots of L-Cysteine Hydrochloride Injection, which is used to meet the amino acid nutritional requirements of infants receiving total parenteral nutrition. Sandoz in an email today said the recalled product had been produced for it by Allergy Labs at its facility in Oklahoma City, but that Sandoz no longer distributes that product.
The recall included 13 lots consisting of 33,624 of its 50 mL vials, and another 6 lots consisting of 18,751 of its 10 mL single dose vials. According to the FDA posting, the recall was initiated “after a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.” That facility had received (PDF) an FDA Form 483 in 2014 after receiving an FDA warning letter in 2013.
Sandoz in March notified (PDF) healthcare providers that the FDA was allowing it to move to import Sandoz Canada’s version “to address the U.S. shortage of this product” since there were no FDA approved products in the U.S. at the time.
In that letter, it said that Sandoz Canada’s L-Cysteine Hydrochloride Injection had the same active ingredient and “is manufactured in compliance with good manufacturing practices in Quebec, Canada at an FDA inspected facility.”
Sandoz said today that beginning in July, Sandoz transitioned supply of its L-Cysteine for injection from Allergy Labs to Sandoz’s Boucherville, Canada, manufacturing facility.
The company made clear that the only product subject to the current recall is the L-Cysteine product which was manufactured by Allergy Labs and is no longer distributed by Sandoz. “The Sandoz Boucherville L-Cysteine product is available for patients and is not subject to any recall,” the company said.
For several years now, the FDA has sometimes allowed manufacturers to bring in products that may have the same active ingredient but are not approved in the U.S. to deal with drug shortages.