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Sandoz Inc has initiated a nationwide recall to 2 lots of injectable methotrexate sodium (25 mg/mL and 40 mL) in the US after they discovered particulate matter in vials during routine quality checks of samples at the manufacturer, the US Food and Drug Administration (FDA) said Tuesday.
The lot numbers and expiration dates of the 2 recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). The lots were distributed nationwide in the US and to a single foreign country (Poland).
"For 1 of the 2 lots (CL0996), the size was 6000 units (vials), of which 1511 were supplied to the market. The rest are on hold. This lot was distributed between December 2012 and May 2013," Chris Lewis, vice president of Communications for Sandoz Inc in Princeton, New Jersey, told Medscape Medical News by email.
"For the second lot (CJ4948), only 124 units/vials were supplied to the US market in May of 2012. None are on hold," Lewis said.
from:
http://www.medscape.com/viewarticle/804542