Glass In Methotrexate Injections Triggers Recall

Methotrexate injection brand Parenta has been recalled by Sandoz Inc. after small glassy flakes were found in some vials. All 50mg/2mL and 250mg/10mL vials are being recalled, the company informs. 24 lots were found to have glass flakes in some of their vials. This occurred because of delamination of the glass which was used to make the vials.


Methotrexate is used for neoplastic disease treatment, such as rheumatoid arthritis, polyarticular juvenile rheumatoid arthritis, and severe psoriasis. It is an antimetabolite - the drug inhibits a normal metabolic process.
The glass particles are big enough to cause adverse reactions in areas where they lodge. There is an "unlikely" risk of serious adverse events, resulting in disability or death after parenteral injection with affected vials, the company adds. Parenteral means "not through the digestive system", such as through the skin.


Injection into the spinal canal (intrathecal administration) using an affected vial could lead to neurologic damage.


Intravenous administration with an affected product raises the risk of blood vessel damage in the lung, granuloma formation, and localized swelling.


Intramuscular injection with an affected vial could result in local pain, swelling and possible long-term granuloma formation.


Intra-arterial injection could damage blood vessels in organs or the distal extremities.


Neither Sandoz nor the FDA has received any reports of adverse events linked to Parenta injections with glass particles.


More details on the recalled products below:

Product : Methotrexate Injection, USP, 50mg/2mL

NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)


Lot number 92395606 - Label type, Parenta - Expiry date, 12/2010
Lot number 92760803 - Label type, Parenta - Expiry date, 2/2011
Lot number 92965104 - Label type, Parenta - Expiry date, 3/2011
Lot number 92965106 - Label type, Parenta - Expiry date, 3/2011
Lot number 92965904 - Label type, Parenta - Expiry date, 4/2011
Lot number 93255704 - Label type, Parenta - Expiry date, 6/2011
Lot number 93502204 - Label type, Parenta - Expiry date, 7/2011
Lot number 93635404 - Label type, Parenta - Expiry date, 8/2011
Lot number 93681704 - Label type, Parenta - Expiry date, 8/2011
Lot number 93794904 - Label type, Sandoz - Expiry date, 9/2011
Lot number 95198604 - Label type, Sandoz - Expiry date, 10/2011
Lot number 95357804 - Label type, Sandoz - Expiry date, 12/2011
Lot number 95537704 - Label type, Sandoz - Expiry date, 1/2012
Lot number 95987004 - Label type, Sandoz - Expiry date, 3/2012


Product : Methotrexate Injection, USP, 250mg/10mL

NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)


Lot number 92395703 - Label type, Parenta - Expiry date, 12/2010
Lot number 92760903 - Label type, Parenta - Expiry date, 2/2011
Lot number 92965203 - Label type, Parenta - Expiry date, 3/2011
Lot number 92966003 - Label type, Parenta - Expiry date, 4/2011
Lot number 93255803 - Label type, Parenta - Expiry date, 6/2011
Lot number 93502303 - Label type, Parenta - Expiry date, 7/2011
Lot number 93635503 - Label type, Parenta - Expiry date, 8/2011
Lot number 93795003 - Label type, Sandoz - Expiry date, 9/2011
Lot number 95198703 - Label type, Sandoz - Expiry date, 10/2011
Lot number 95357903 - Label type, Sandoz - Expiry date, 12/2011

Sources: Sandoz, FDA


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